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Xu C, Fan S, Tian Y, Liu F, Furuya-Kanamori L, Clark J, Zhang C, Li S, Lin L, Chu H, Li S, Golder S, Loke Y, Vohra S, Glasziou P, Doi SA, Liu H. Investigating the impact of trial retractions on the healthcare evidence ecosystem (VITALITY Study I): retrospective cohort study. BMJ 2025; 389:e082068. [PMID: 40268307 PMCID: PMC12015725 DOI: 10.1136/bmj-2024-082068] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/10/2025] [Indexed: 04/25/2025]
Abstract
OBJECTIVE To investigate the impact of retracted trials on the production and use of healthcare evidence in the evidence ecosystem. DESIGN Retrospective cohort study based on forward citation searching. DATA SOURCES Retraction Watch up to 5 November 2024. STUDY SELECTION Randomised controlled trials in humans that were retracted for any reason. METHODS Forward citation searching via Google Scholar and Scopus was used to identify evidence synthesis research (21 November 2024) that quantitatively incorporated retracted trials. Data were independently extracted by two groups of researchers. The results of meta-analyses were updated after exclusion of the retracted trials. The proportions of meta-analyses that changed direction of the pooled effect and/or the significance of the P value were estimated. A generalised linear mixed model was used to investigate the association between the number of included studies and the impact, measured by odds ratio and 95% confidence interval (CI). The impact of distorted evidence on clinical practice guidelines was also investigated on the basis of citation searching. RESULTS The searches identified 1330 retracted trials and 847 systematic reviews that quantitatively synthesised retracted trials, with a total of 3902 meta-analyses that could be replicated. After the potential clustering effects were accounted for, the exclusion of the retracted trials led to a change in the direction of the pooled effect in 8.4% (95% CI 6.8% to 10.1%), in its statistical significance in 16.0% (14.2% to 17.9%), and in both direction and significance in 3.9% (2.5% to 5.2%) and a >50% change in the magnitude of the effect in 15.7% (13.5% to 17.9%). An obvious non-linear association existed between the number of included studies and the impact on the results, with a lower number of studies having higher impact (eg, for 10 studies versus ≥20 studies, change of direction: odds ratio 2.63, 95% CI 1.29 to 5.38; P<0.001). Evidence from 68 systematic reviews with conclusions distorted by retracted trials was used in 157 guideline documents. CONCLUSION Retracted trials have a substantial impact on the evidence ecosystem, including evidence synthesis, clinical practice guidelines, and evidence based clinical practice. Evidence generators, synthesisers, and users must pay attention to this problem, and feasible approaches that assist with easier identification and correction of such potential contamination are needed. STUDY REGISTRATION Open Science Framework (https://osf.io/7eazq/).
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Affiliation(s)
- Chang Xu
- Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
| | - Shiqi Fan
- Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
| | - Yuan Tian
- Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
| | - Fuchen Liu
- The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
| | - Luis Furuya-Kanamori
- UQ Centre for Clinical Research, University of Queensland, Herston, Queensland, Australia
| | - Justin Clark
- Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia
| | - Chao Zhang
- Center of Evidence-based Medicine, Taihe Hospital, Hubei University of Medicine, Shiyan, China
| | - Sheng Li
- Office of Research Affairs, Zhongnan Hospital of Wuhan University, Wuhan, China
| | - Lifeng Lin
- Department of Epidemiology and Biostatistics, University of Arizona, Tucson, AZ, USA
| | - Haitao Chu
- Statistical Research and Data Science Center, Global Biometrics and Data Management, Pfizer Inc, New York, NY, USA
- Division of Biostatistics and Health Data Science, University of Minnesota School of Public Health, Minneapolis, Minnesota, MN, USA
| | - Sheyu Li
- Department of Endocrinology and Metabolism, Division of Guideline and Rapid Recommendation, Cochrane China Centre, MAGIC China Centre, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, China
| | - Su Golder
- Department of Health Sciences, University of York, York, UK
| | - Yoon Loke
- Norwich Medical School, University of East Anglia, Norwich, UK
| | - Sunita Vohra
- Department of Pediatrics, Faculty of Medicine & Dentistry; Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada
| | - Paul Glasziou
- Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia
| | - Suhail A Doi
- Department of Population Medicine, College of Medicine, QU Health, Qatar University, Doha, Qatar
| | - Hui Liu
- Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
- The Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China
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Delaye-Martínez MA, Vanegas-Rodríguez ES, Mendez-Sotelo B, García-Hernández MDL, Colín-Castro CA, Franco-Cendejas R, López-Jácome LE. Polymicrobial Osteomyelitis in a Patient With Isolation of Trueperella bernardiae: A Case Report and Literature Review. Case Rep Infect Dis 2025; 2025:6010539. [PMID: 39949483 PMCID: PMC11824385 DOI: 10.1155/crdi/6010539] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/27/2024] [Accepted: 12/26/2024] [Indexed: 02/16/2025] Open
Abstract
Background: Trueperella bernardiae is a Gram-positive rod that has been described as an opportunistic pathogen in immunocompromised patients. In a significant number of documented cases, infections with Trueperella bernardiae have been associated with polymicrobial infections, which highlight the fact that important bacteria-bacteria relations might be involved in the natural course of these infections, especially in patients with chronic disease courses and a history of multiple antibiotic treatments. Case Presentation: We present a case of a 24-year-old woman with a 3-year history of a chronic pressure ulcer on the right foot associated with varus and cavus deformity. As per relevant medical history, she was positive for multiple wound healing sessions with wound debridement and a large number of antibiotic treatments with minimal improvement. Microbiological cultures were taken from the wound, and a soft tissue infection diagnosis was initially made. Empirical treatment was initiated with levofloxacin. At 48 h, cultures were positive for Providencia stuartii, Pseudomonas aeruginosa, Proteus penneri, Streptococcus agalactiae, and Trueperella bernardiae, and the susceptibility test was performed. Three weeks later, the symptoms progressed to purulent exudate of the wound and foul-smelling with the positive probe-to-bone test. Diagnosis was changed to polymicrobial osteomyelitis, and antibiotic therapy with ciprofloxacin and trimethoprim-sulfamethoxazole was prescribed for a 4-week course of treatment, achieving the complete remission of symptoms. Conclusions: Trueperella bernardiae represents an emerging bacterium that can be isolated in various clinical presentations. On osteoarticular infections, the presence of comorbidities, mobility limitations, and a history of multiple antibiotic treatments may be determinant. Their isolation as part of polymicrobial infections highlights relevant interspecies interactions. Research is still lacking in determining standardized methodologies for susceptibility testing and specific clinical breakpoints to guide clinical decisions.
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Affiliation(s)
- Marco Antonio Delaye-Martínez
- Department of Infectious Diseases, Instituto Nacional de Cancerología, Mexico City 14080, Mexico
- PECEM, Facultad de Medicina, Universidad Nacional Autónoma de México, Mexico City 0436, Mexico
| | - Edgar Samuel Vanegas-Rodríguez
- Division of Infectious Diseases, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City 14389, Mexico
| | - Braulio Mendez-Sotelo
- Division of Infectious Diseases, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City 14389, Mexico
| | - María de Lourdes García-Hernández
- Clinical Microbiology Laboratory, Infectious Diseases Division, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City 14389, Mexico
| | - Claudia Adriana Colín-Castro
- Clinical Microbiology Laboratory, Infectious Diseases Division, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City 14389, Mexico
| | - Rafael Franco-Cendejas
- Biomedical Research Subdirection, Research Direction, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City 14389, Mexico
| | - Luis Esaú López-Jácome
- Clinical Microbiology Laboratory, Infectious Diseases Division, Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City 14389, Mexico
- Department of Biology, Chemistry Faculty, Universidad Nacional Autónoma de México, Mexico City 04510, Mexico
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Argenziano G, Ardigò M, Micali G, Nasca MR, Scilletta A, Tognetti L, Rubegni P, Veraldi S. Review - Expert Opinion on Antibiotics and Antibiotic Resistance in Dermatology. Dermatol Pract Concept 2024; 14:dpc.1404a282. [PMID: 39392426 PMCID: PMC11620216 DOI: 10.5826/dpc.1404a282] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/15/2024] [Indexed: 10/12/2024] Open
Abstract
INTRODUCTION Antibiotic resistance has become a serious, severe problem worldwide. This issue does not only relate to the use of systemic antibiotics but to topical ones as well, like systemic therapies and local treatment of skin and mucosal infections. Antiseptics, an alternative to the topical treatment with antibiotics of wounds and some inflammatory dermatological conditions, tend to be microbicidal and have a broader spectrum of antimicrobial activity than antibiotics. Among these, polyhexanide (PHMB) allows for the control of the infection while avoiding the development of resistance. OBJECTIVES Recommendations on the rules of good clinical practice for the management of small wounds, burns and post-traumatic ulcerative wounds, impetigo or folliculitis in the initial stages, and acne. METHODS Literature review on the principal topical therapies for small wounds, injuries, impetigo, folliculitis, and acne and a proposal of innovative, highly-tolerated treatments. RESULTS AND CONCLUSIONS Given the abuse of topical antibiotics in dermatology, for the treatment of small wounds, injuries, localized folliculitis, impetigo, and acne, the use of alternative topical treatments like polyhexanide and Rigenase® is recommended.
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Affiliation(s)
| | - Marco Ardigò
- Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
| | | | | | | | - Linda Tognetti
- U.O.C. Dermatologia, Dipartimento Scienze Mediche, Chirurgiche e neuroscienze, Università degli studi di Siena, Siena
| | - Pietro Rubegni
- U.O.C. Dermatologia, Dipartimento Scienze Mediche, Chirurgiche e neuroscienze, Università degli studi di Siena, Siena
| | - Stefano Veraldi
- Corso di Clinica Dermatologica, Università di Milano Bicocca e Ospedale San Raffaele, Milano
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Tajdar Y, Singh S, Raj A, Raj A, Bhushan V. Effect of silver colloid dressing over conventional dressings in diabetic foot ulcer: A prospective study. Turk J Surg 2024; 40:28-35. [PMID: 39036009 PMCID: PMC11257724 DOI: 10.47717/turkjsurg.2024.6168] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2023] [Accepted: 03/04/2024] [Indexed: 07/23/2024]
Abstract
Objectives Topical silver treatments and silver dressings are increasingly being utilized for the local treatment of wounds; nevertheless, the evidence for their usefulness is unclear. The aim of this study was to investigate the impact of conventional dressings and silver colloid dressing on diabetic foot ulcers (DFU) with and without compression therapy. Material and Methods This prospective, double-blind experiment included 50 patients with non-ischemic DFUs, split into two groups of 25 patients each. The study was conducted for a period of six months. The primary endpoint was to evaluate the entire epithelialization (total healing) of all ulcers on the study leg. Results The ulcer area significantly decreased in the colloidal silver group (67.77 ± 17.82%) compared to the conventional saline group (21.70 ± 23.52%). When compared to the conventional group, the colloidal silver group required considerably fewer days to reach the endpoint (23.15 ± 8.15 days vs. 48.35 ± 18.07 days), and by day 14, ulcer area reduction (from 100%) was greater (48% in the silver group vs. 89.69% in the conventional group). Conclusion In managing DFUs, unstructured hydrogel wound dressings using silver colloids based on ionic silver are more effective than regular saline dressings since they heal wounds more quickly in fewer days while also drastically reducing ulcer areas over time.
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Affiliation(s)
- Yasir Tajdar
- Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Patna, India
| | - Sakshi Singh
- Department of Surgery, Indira Gandhi Institute of Medical Sciences, Patna, India
| | - Ankit Raj
- Department of Surgery, Indira Gandhi Institute of Medical Sciences, Patna, India
| | - Ayush Raj
- Department of General Surgery, Indira Gandhi Institute of Medical Sciences, Patna, India
| | - Vibhuti Bhushan
- Department of Surgery, Indira Gandhi Institute of Medical Sciences, Patna, India
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Mohamady HM, Taha MM, Aneis YM, Aldhahi MI, Attalla AF. Effect of Combined Electromagnetic Field and Plantar Flexion Resistance Exercise on Wound Healing in Patients with Venous Leg Ulcers: A Randomized Controlled Trial. MEDICINA (KAUNAS, LITHUANIA) 2023; 59:1157. [PMID: 37374361 DOI: 10.3390/medicina59061157] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/01/2023] [Revised: 05/16/2023] [Accepted: 06/12/2023] [Indexed: 06/29/2023]
Abstract
Background and Objectives: Venous ulcers are recognized to be more painful and resistant to therapy than ulcers of other etiologies. Various methods have been used for the conservative treatment of venous ulcers, such as pulsed electromagnetic field (PEMF) and plantar exercise, which promote wound healing due to a range of physiological effects. The study aimed to examine the effect of combined pulsed electromagnetic field therapy and plantar flexion resistance exercise (PRE) on patients with venous leg ulcers (VLUs). Materials and Methods: The study was a prospective, randomized controlled trial. A total of 60 patients between the ages of 40 and 55 with venous ulcers were randomly assigned to 1 of 3 groups. For up to 12 weeks, the first group received PEMF therapy and plantar flexion resistance exercise (PRE) therapy in addition to conservative ulcer treatment for up to 12 weeks. The second group received only PEMF therapy in addition to conservative ulcer treatment, while the third group served as the control and received only conservative ulcer treatment. Results: At the four-week follow-up, the two experimental groups revealed a considerable variation in ulcer surface area (USA) and ulcer volume (UV), with no significant change in the control group. At the 12-week follow-up, there were significant differences between the three groups, while group A underwent the most significant changes, with mean differences at [95% confidence interval] of (-4.75, -3.82, -0.98) for USA and (-12.63, -9.55, -2.45) for UV, respectively. Conclusions: On a short-term basis, adding a plantar resistance exercise to the PEMF had no appreciable short-term effects on ulcer healing; however, their combination had more pronounced medium-term effects.
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Affiliation(s)
- Heba Mohamed Mohamady
- Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza 11432, Egypt
| | - Mona Mohamed Taha
- Department of Rehabilitation Sciences, College of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, P.O. Box 84428, Riyadh 11671, Saudi Arabia
| | - Yasser M Aneis
- Department of Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza 11432, Egypt
- Department of Basic Sciences, Faculty of Physical Therapy, Delta University for Science and Technology, Gamasa City 11152, Egypt
| | - Monira I Aldhahi
- Department of Rehabilitation Sciences, College of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, P.O. Box 84428, Riyadh 11671, Saudi Arabia
| | - Asmaa Fawzy Attalla
- Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza 11432, Egypt
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Sang S, Wang S, Wu J, Zhang X. Sprayable Berberine-Silk Fibroin Microspheres with Extracellular Matrix Anchoring Function Accelerate Infected Wound Healing through Antibacterial and Anti-inflammatory Effects. ACS Biomater Sci Eng 2023. [PMID: 37142304 DOI: 10.1021/acsbiomaterials.3c00030] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/06/2023]
Abstract
The conventional method of applying local medications for treating wound infections is often ineffective because of the dilution of drugs by the excess wound exudate. In addition, there have been insufficient studies investigating the adhesion between drug-loaded nanomaterials and cells or tissue. To address this intractable problem, berberine-silk fibroin microspheres (Ber@MPs) with an extracellular matrix-anchoring function were developed in this study. The microspheres were prepared from silk fibroin using the polyethylene glycol emulsion precipitation method. Subsequently, berberine was loaded onto the microspheres. Our results revealed that Ber@MPs firmly anchored to cells, continuously releasing berberine in the microenvironment. Moreover, both Ber@MPs and Ber@MPs-cell complexes exerted a strong and long-lasting antibacterial effect against Staphylococcus aureus and Staphylococcus epidermidis in the microenvironment, despite the large amount of wound exudate. In addition, Ber@MPs effectively resisted the inflammatory response induced by lipopolysaccharides and accelerated the migration of fibroblasts and neovascularization of endothelial cells cultured in inflammation-induced media. Finally, the in vivo experiments confirmed that the Ber@MP spray accelerated the healing of infected wounds via its antibacterial and anti-inflammatory effects. Therefore, this study provides a novel strategy for treating infected wounds in the presence of excess exudate.
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Affiliation(s)
- Shang Sang
- Department of Orthopaedics, Shanghai Sixth People' Hospital, Shanghai 200233, China
| | - Shengjie Wang
- Department of Orthopaedics, Shanghai Sixth People' Hospital, Shanghai 200233, China
| | - Jianbing Wu
- College of Textile, Garment and Design, Changshu Institute of Technology, Suzhou 215500, China
| | - Xianlong Zhang
- Department of Orthopaedics, Shanghai Sixth People' Hospital, Shanghai 200233, China
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Musayeva AM. New approach to pathogenesis and treatment of trophycal ulcers. BULLETIN OF THE MEDICAL INSTITUTE "REAVIZ" (REHABILITATION, DOCTOR AND HEALTH) 2023. [DOI: 10.20340/vmi-rvz.2023.1.morph.3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 03/30/2023]
Abstract
Introduction. Trophic ulcers are one of the most common medical ailments worldwide. Treatment of patients with trophic ulcers is difficult not only because they often recur, but also because they are difficult to treat. Purpose. Study the clinical features and present our own results of combined methods of treatment of trophic ulcers of venous etiology. Materials and methods. The study involved 100 patients with trophic ulcers of the lower extremities of venous, diabetic and atherosclerotic etiology, who had a history and were treated for varicose veins of the lower extremities and post-thrombotic disease. Examination of patients included questionnaires, clarification of complaints, anamnesis data, causes of development, examination and ultrasound diagnostics (duplex examination). The examination of the ulcer included determining the location, size, appearance, base of the wound, the level of exudation and assessment of the condition of the skin around the defect. Results. The etiological factors in the development of trophic ulcers were: varicose disease with chronic venous insufficiency – 25 patients, post-thrombotic disease – 55 patients. All patients underwent only conservative treatment of trophic venous ulcers with the appointment of a placenta compositum. After the treatment of a group of patients, out of 100 patients with venous trophic ulcers, 89% were cured within 4 months, 8% were cured within 2 years, and in 3 % ulcers did not heal for more than two years. The average duration of the course of ulcers was 12 months. The average size of trophic ulcers based on the results of the analysis was 8 cm2. Complete healing of venous ulcers was most often observed in the age group 61–73 years in 30% patients. Conclusion. The use of the compositum placenta contributed to the acceleration of wound healing, which made it possible to obtain more effective results.
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Caputo WJ, Monterosa P, Beggs D. Antibiotic Misuse in Wound Care: Can Bacterial Localization through Fluorescence Imaging Help? Diagnostics (Basel) 2022; 12:3207. [PMID: 36553214 PMCID: PMC9778012 DOI: 10.3390/diagnostics12123207] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2022] [Revised: 12/07/2022] [Accepted: 12/13/2022] [Indexed: 12/23/2022] Open
Abstract
(1) Background: Systemic antibiotic use in chronic wounds is alarmingly high worldwide. Between 53% to 71% of patients are prescribed at least one course per chronic wound. Systemic antibiotic use should follow antibiotic stewardship guidelines and ought to be reserved for situations where their use is deemed supported by clinical indications. Unfortunately, in the field of wound care, indiscriminate and often inadequate use of systemic antibiotics is leading to both patient complications and worsening antibiotic resistance rates. Implementing novel tools that help clinicians prevent misuse or objectively determine the true need for systemic antibiotics is essential to reduce prescribing rates. (2) Methods: We present a compendium of available systemic antibiotic prescription rates in chronic wounds. The impact of various strategies used to improve these rates, as well as preliminary data on the impact of implementing fluorescence imaging technology to finesse wound status diagnosis, are presented. (3) Results: Interventions including feedback from wound care surveillance and treatment data registries as well as better diagnostic strategies can ameliorate antibiotic misuse. (4) Conclusions: Interventions that mitigate unnecessary antibiotic use are needed. Effective strategies include those that raise awareness of antibiotic overprescribing and those that enhance diagnosis of infection, such as fluorescence imaging.
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Affiliation(s)
- Wayne J. Caputo
- Director of the Wound Care Center at Clara Maass Medical Center, Belleville, NJ 07109, USA
| | | | - Donald Beggs
- Infectious Disease, Clara Maass Medical Center, Belleville, NJ 07109, USA
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Zheng H, Magee GA, Tan TW, Armstrong DG, Padula WV. Cost-effectiveness of Compression Therapy With Early Endovenous Ablation in Venous Ulceration for a Medicare Population. JAMA Netw Open 2022; 5:e2248152. [PMID: 36542379 PMCID: PMC9857339 DOI: 10.1001/jamanetworkopen.2022.48152] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2022] [Accepted: 11/06/2022] [Indexed: 12/24/2022] Open
Abstract
Importance Venous leg ulcers (VLU) are the most common cause of lower extremity ulceration that commonly occur among older individuals and are characterized by a slow healing trajectory and frequent recurrence; in the United States, VLUs affect more than 600 000 people per year with an estimated cost of $3.5 billion. Clinical trial data show that early intervention with endovenous ablation substantially improves the healing rate and reduces recurrence among patients with VLUs, but there is a need to assess the cost-effectiveness of early endovenous ablation in the US context. Objectives To evaluate the cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with VLU from the US Medicare perspective. Design, Setting, and Participants This economic evaluation used a Markov model to simulate the disease progression of VLU for patients receiving compression therapy with early vs deferred ablation over 3 years. The simulated cohort included patients with VLU aged 65 years and older who had clinical characteristics similar to those in the randomized Early Venous Reflux Ablation trial in the United Kingdom. Data were analyzed from September 2021 to June 2022. Main Outcomes and Measures Direct medical costs, quality-adjusted life years (QALYs), and the incremental monetary benefits at a willingness-to-pay threshold of $100 000/QALY. Univariate and probabilistic sensitivity analyses were performed to test uncertainty of model results. Results This model used a simulated cohort of patients with VLU aged 65 years and older enrolled in Medicare. Early ablation dominated, with a lower per-patient cost of $12 527 and an increase of 2.011 QALYs, whereas compression therapy with deferred ablation yielded a per-patient cost of $15 208 and 1.985 QALYs gained. At a $100 000/QALY cost-effectiveness threshold, the incremental net monetary benefit was $5226 per patient in favor of early ablation. Probability of healing, followed by the probability of recurrence, was the parameter with greatest impact on model uncertainty. The probabilistic sensitivity analysis showed that early ablation was cost-effective in 59.2% of simulations at the $100 000/QALY threshold. Conclusions and Relevance In this economic evaluation of compression therapy with early endovenous ablation, early intervention was dominant, as it was cost saving and generated greater QALYs over 3 years from the US Medicare perspective. Payers should prioritize coverage for early ablation to prevent VLU complications rather than treat a costly outcome that also reduces patient well-being.
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Affiliation(s)
- Hanke Zheng
- Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles
| | - Gregory A. Magee
- Division of Vascular Surgery, Department of Surgery, Keck Medicine of University of Southern California, Los Angeles
- Southwestern Academic Limb Salvage Alliance (SALSA), Tucson, Arizona
| | - Tze-Woei Tan
- Southwestern Academic Limb Salvage Alliance (SALSA), Tucson, Arizona
- College of Medicine, Department of Surgery, University of Arizona, Tucson
| | - David G. Armstrong
- Division of Vascular Surgery, Department of Surgery, Keck Medicine of University of Southern California, Los Angeles
- Southwestern Academic Limb Salvage Alliance (SALSA), Tucson, Arizona
- Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles
| | - William V. Padula
- Department of Pharmaceutical and Health Economics, School of Pharmacy, University of Southern California, Los Angeles
- Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles
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Antibiofilm Properties of Antiseptic Agents Used on Pseudomonas aeruginosa Isolated from Diabetic Foot Ulcers. Int J Mol Sci 2022; 23:ijms231911270. [PMID: 36232569 PMCID: PMC9569737 DOI: 10.3390/ijms231911270] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/03/2022] [Revised: 09/11/2022] [Accepted: 09/13/2022] [Indexed: 11/16/2022] Open
Abstract
In diabetic foot ulcers (DFUs), biofilm formation is a major challenge that promotes wound chronicity and delays healing. Antiseptics have been proposed to combat biofilms in the management of DFUs. However, there is limited evidence on the activity of these agents against biofilms, and there are questions as to which agents have the best efficiency. Here, we evaluated the antibiofilm activity of sodium hypochlorite, polyvinylpyrrolidoneIodine (PVPI), polyhexamethylenebiguanide (PHMB) and octenidine against Pseudomonas aeruginosa strains using static and dynamic systems in a chronic-wound-like medium (CWM) that mimics the chronic wound environment. Using Antibiofilmogram®, a technology assessing the ability of antiseptics to reduce the initial phase of biofilm formation, we observed the significant activity of antiseptics against biofilm formation by P. aeruginosa (at 1:40 to 1:8 dilutions). Moreover, 1:100 to 1:3 dilutions of the different antiseptics reduced mature biofilms formed after 72 h by 10-log, although higher concentrations were needed in CWM (1:40 to 1:2). Finally, in the BioFlux200TM model, after biofilm debridement, sodium hypochlorite and PHMB were the most effective antiseptics. In conclusion, our study showed that among the four antiseptics tested, sodium hypochlorite demonstrated the best antibiofilm activity against P. aeruginosa biofilms and represents an alternative in the management of DFUs.
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Mansilha A, Gianesini S, Ulloa JH, Lobastov K, Wang J, Freitag A, Schaible KR, Martin M, Yaltirik P, Nicolaides AN. Pharmacological treatment for chronic venous disease: an umbrella review of systematic reviews. INT ANGIOL 2022; 41:249-257. [PMID: 35373942 DOI: 10.23736/s0392-9590.22.04877-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
INTRODUCTION Chronic venous disease is a persistent venous drainage alteration caused by valvular incompetence and/or outflow obstruction. Disease management includes a variety of treatments, whose evidence and clinical performance in the mid-long term are variable. The objective of this umbrella review was to summarize efficacy data for pharmacological treatments including venoactive drugs from previously published reviews that included a meta-analytic component. EVIDENCE ACQUISITION Systematic database searches were conducted via Ovid SP on 13 August 2019, covering MEDLINE, Embase, and the Cochrane Database of Systematic Reviews. Reviews that included a meta-analytic component of four or more clinical trials or observational studies reporting on the efficacy of systemic or topical pharmacological treatments for adults with chronic venous disease published since 2010 were eligible for inclusion. EVIDENCE SYNTHESIS Eleven publications were included in this umbrella review. Change in ankle circumference was the most commonly reported outcome. Overall, several systemic treatments had significant effects compared with placebo on multiple efficacy outcomes, including measures of edema and pain. Out of them, Micronized Purified Flavonoid Fraction had the most comprehensive evidence of effectiveness on main symptoms and signs and on improving quality of life throughout chronic venous disease stages. CONCLUSIONS Systemic pharmacotherapies represent a valuable therapeutic option in CVD management. As a result of this umbrella review, several gaps were identified with respect to research topics that warrant further investigation, particularly in the category of topical medications.
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Affiliation(s)
| | - Sergio Gianesini
- Vascular Diseases Center, Department of Translational Medicine, University of Ferrara, Ferrara, Italy
- Department of Surgery, Uniformed Services University of Health Sciences, Bethesda, MD, USA
| | - Jorge H Ulloa
- Division of Vascular Surgery, Department of Surgery, University of the Andes, Bogota, Colombia
| | - Kirill Lobastov
- Pirogov Russian National Research Medical University, Moscow, Russia
| | - Jinsong Wang
- Affiliated Hospital Sun Yat-Sen University, Guangzhou, China
| | | | | | | | - Pelin Yaltirik
- Internal Medicine and Neuropsychiatry, Global Medical and Patient Affairs (GMPA), Servier, Suresnes, France
| | - Andrew N Nicolaides
- Medical School, Department of Surgery, University of Nicosia, Nicosia, Cyprus
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12
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Ding X, Tang Q, Xu Z, Xu Y, Zhang H, Zheng D, Wang S, Tan Q, Maitz J, Maitz PK, Yin S, Wang Y, Chen J. Challenges and innovations in treating chronic and acute wound infections: from basic science to clinical practice. BURNS & TRAUMA 2022; 10:tkac014. [PMID: 35611318 PMCID: PMC9123597 DOI: 10.1093/burnst/tkac014] [Citation(s) in RCA: 76] [Impact Index Per Article: 25.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/10/2021] [Revised: 02/06/2022] [Indexed: 12/30/2022]
Abstract
Acute and chronic wound infection has become a major worldwide healthcare burden leading to significantly high morbidity and mortality. The underlying mechanism of infections has been widely investigated by scientist, while standard wound management is routinely been used in general practice. However, strategies for the diagnosis and treatment of wound infections remain a great challenge due to the occurrence of biofilm colonization, delayed healing and drug resistance. In the present review, we summarize the common microorganisms found in acute and chronic wound infections and discuss the challenges from the aspects of clinical diagnosis, non-surgical methods and surgical methods. Moreover, we highlight emerging innovations in the development of antimicrobial peptides, phages, controlled drug delivery, wound dressing materials and herbal medicine, and find that sensitive diagnostics, combined treatment and skin microbiome regulation could be future directions in the treatment of wound infection.
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Affiliation(s)
- Xiaotong Ding
- School of Pharmacy, Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing University of Chinese Medicine, Nanjing 210023, People's Republic of China
| | - Qinghan Tang
- School of Pharmacy, Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing University of Chinese Medicine, Nanjing 210023, People's Republic of China
| | - Zeyu Xu
- School of Pharmacy, Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing University of Chinese Medicine, Nanjing 210023, People's Republic of China
| | - Ye Xu
- Department of Burns and Plastic Surgery, The affiliated Drum Tow Hospital of Nanjing University of Chinese Medicine, Nanjing 210008, People's Republic of China
| | - Hao Zhang
- Department of Burns and Plastic Surgery, The affiliated Drum Tow Hospital of Nanjing University of Chinese Medicine, Nanjing 210008, People's Republic of China
| | - Dongfeng Zheng
- Department of Burns and Plastic Surgery, The affiliated Drum Tow Hospital of Nanjing University of Chinese Medicine, Nanjing 210008, People's Republic of China
| | - Shuqin Wang
- Department of Burns and Plastic Surgery, The affiliated Drum Tow Hospital of Nanjing University of Chinese Medicine, Nanjing 210008, People's Republic of China
| | - Qian Tan
- Department of Burns and Plastic Surgery, The affiliated Drum Tow Hospital of Nanjing University of Chinese Medicine, Nanjing 210008, People's Republic of China
| | - Joanneke Maitz
- Burns Injury and Reconstructive Surgery Research, ANZAC Research Institute, University of Sydney, Sydney, Australia, 2137
| | - Peter K Maitz
- Burns Injury and Reconstructive Surgery Research, ANZAC Research Institute, University of Sydney, Sydney, Australia, 2137
| | - Shaoping Yin
- School of Pharmacy, Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing University of Chinese Medicine, Nanjing 210023, People's Republic of China
| | - Yiwei Wang
- School of Pharmacy, Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing University of Chinese Medicine, Nanjing 210023, People's Republic of China
| | - Jun Chen
- School of Pharmacy, Jiangsu Provincial Engineering Research Center of Traditional Chinese Medicine External Medication Development and Application, Nanjing University of Chinese Medicine, Nanjing 210023, People's Republic of China
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13
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Cacua Sanchez MT, Buenahora G. Socio-Demographic Characteristics and Associated Factors of Morbidity in Patients with Venous Ulcers Treated in Two Institutions of Contributive and Subsidized Regime in Colombia: Retrospective, Multicenter, Observational Study. Vasc Health Risk Manag 2022; 18:89-104. [PMID: 35264854 PMCID: PMC8901223 DOI: 10.2147/vhrm.s345542] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2021] [Accepted: 01/09/2022] [Indexed: 11/23/2022] Open
Abstract
Aim Objective Methodology Results Conclusion
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Affiliation(s)
- Maria Teresa Cacua Sanchez
- Vascular Surgery, Ambulatory Surgery Center, Vascular Laboratory Kennedy Hospital, Bogotá, Colombia
- Correspondence: Maria Teresa Cacua Sanchez, Tel +57-1-3057470125, Email
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14
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Ghomi ER, Shakiba M, Ardahaei AS, Akbari M, Faraji M, Ataei S, Kohansal P, Jafari I, Abdouss M, Ramakrishna S. Innovations in drug delivery for chronic wound healing. Curr Pharm Des 2021; 28:340-351. [PMID: 34269663 DOI: 10.2174/1381612827666210714102304] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2021] [Revised: 05/24/2021] [Accepted: 06/03/2021] [Indexed: 11/22/2022]
Abstract
Wound healing is a varied and complex process designed to promptly restore standard skin structure, function, and appearance. To achieve this goal, different immune and biological systems participate in coordination through four separate steps, including homeostasis, inflammation, proliferation, and regeneration. Each step involves the function of other cells, cytokines, and growth factors. However, chronic ulcers, which are classified into three types of ulcers, namely vascular ulcers, diabetic ulcers, and pressure ulcers, cannot heal through the mentioned natural stages. It causes mental and physical problems for these people and, as a result, imposes high economic and social costs on society. In this regard, using a system that can accelerate the healing process of such chronic wounds, as an urgent need in the community, should be considered. Therefore, in this study, the innovations of drug delivery systems for the healing of chronic wounds using hydrogels, nanomaterial, and membranes are discussed and reviewed.
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Affiliation(s)
- Erfan Rezvani Ghomi
- Center for Nanotechnology and Sustainability, Department of Mechanical Engineering, Faculty of Engineering, Singapore 117581, Singapore
| | | | - Ali Saedi Ardahaei
- Department of Polymer Engineering, Faculty of Engineering, Golestan University, Gorgan, P.O. Box 491888369, Iran
| | - Mahsa Akbari
- Department of Chemistry, Amirkabir University of Technology, Tehran, Iran
| | - Mehdi Faraji
- School of Chemistry, College of Science, University of Tehran, P.O. Box 14155-6455, Tehran, Iran
| | - Shahla Ataei
- Department of Chemical Engineering, Isfahan University of Technology, Isfahan, 84156-83111, Iran
| | - Parisa Kohansal
- Department of Chemistry, Amirkabir University of Technology, Tehran, Iran
| | - Iman Jafari
- Department of Civil and Environmental Engineering, Faculty of Engineering, National University of Singapore, Singapore 117576, Singapore
| | - Majid Abdouss
- Department of Chemistry, Amirkabir University of Technology, Tehran, Iran
| | - Seeram Ramakrishna
- Center for Nanotechnology and Sustainability, Department of Mechanical Engineering, Faculty of Engineering, Singapore 117581, Singapore
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15
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Lu YX, Wu Y, Liang PF, Wu RC, Tian LY, Mo HY. Efficacy of combination of localized closure, ethacridine lactate dressing, and phototherapy in treatment of severe extravasation injuries: A case series. World J Clin Cases 2021; 9:4599-4606. [PMID: 34222426 PMCID: PMC8223846 DOI: 10.12998/wjcc.v9.i18.4599] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2020] [Revised: 02/24/2021] [Accepted: 04/06/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The management of severe extravasation injuries is still controversial. Extravasation injuries can be treated in many ways.
AIM To present a series of patients with severe extravasation injuries due to infusion who were managed with ethacridine lactate dressing combined with localized closure and phototherapy.
METHODS In this study, we evaluated the data of eight patients, including six from the Department of Burn, one (with colorectal carcinoma) from the Veteran Cadre Department, and one (with leukemia) from the Hematology Department. Of these, three patients were male and five were female. Age of the patients ranged from 10 mo to 72 years, including two children (10 and 19 mo of age). In this study, the infusion was stopped immediately when the extravasation was identified. The extravasation event was managed routinely using a blocking solution. A ring-shaped localized closure was performed using the blocking agents. Moreover, ethacridine lactate dressing and phototherapy were applied for 3-5 d.
RESULTS In this study, the drugs contained in the infusates were iodixanol, norepinephrine, alprostadil, amino acids, fat emulsion, cefoselis, cefoxitin, and potassium chloride + concentrated sodium chloride. All of the patients achieved complete healing after treatment and no obvious adverse reactions were observed.
CONCLUSION The treatment of severe extravasation injuries using a combination of localized closure, ethacridine lactate dressing, and phototherapy resulted in satisfactory outcomes in patients.
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Affiliation(s)
- Yan-Xu Lu
- Xiangya Stomatological Hospital & School of Stomatology , Central South University, Changsha 410000, Hunan Province, China
| | - Ying Wu
- Teaching and Research Section of Clinical Nursing, Department of Burn and Reconstructive Surgery, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China
| | - Peng-Fei Liang
- Department of Burn and Reconstructive Surgery, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China
| | - Rong-Chan Wu
- Phase 1 Clinical Trial Center, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China
| | - Ling-Yun Tian
- School of Nursing, Anhui University of Chinese Medicine, Hefei 230012, Anhui Province, China
| | - Hui-Ying Mo
- Department of Burn and Reconstructive Surgery, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China
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16
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Schroeppel DeBacker SE, Bulman JC, Weinstein JL. Wound Care for Venous Ulceration. Semin Intervent Radiol 2021; 38:194-201. [PMID: 34108806 PMCID: PMC8175111 DOI: 10.1055/s-0041-1727161] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Venous leg ulcers (VLUs) affect as many as 20% of patients with advanced chronic venous insufficiency and are associated with significant morbidity and health care costs. VLUs are the most common cause of leg ulcers; however, other etiologies of lower extremity ulcerations should be investigated, most notably arterial insufficiency, to ensure appropriate therapy. Careful clinical examination, standardized documentation, and ultrasound evaluation are needed for diagnosis and treatment success. Reduction of edema and venous hypertension through compression therapy, local wound care, and treatment of venous reflux or obstruction is the foundation of therapy. As key providers in venous disease, interventional radiologists should be aware of current standardized disease classification and scoring systems as well as treatment and wound care guidelines for venous ulcers.
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Affiliation(s)
| | - Julie C. Bulman
- Harvard Medical School, Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
| | - Jeffrey L. Weinstein
- Harvard Medical School, Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
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17
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Maillard JY, Kampf G, Cooper R. Antimicrobial stewardship of antiseptics that are pertinent to wounds: the need for a united approach. JAC Antimicrob Resist 2021; 3:dlab027. [PMID: 34223101 PMCID: PMC8209993 DOI: 10.1093/jacamr/dlab027] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
Long before the nature of infection was recognized, or the significance of biofilms in delayed healing was understood, antimicrobial agents were being used in wound care. In the last 70 years, antibiotics have provided an effective means to control wound infection, but the continued emergence of antibiotic-resistant strains and the documented antibiotic tolerance of biofilms has reduced their effectiveness. A range of wound dressings containing an antimicrobial (antibiotic or non-antibiotic compound) has been developed. Whereas standardized methods for determining the efficacy of non-antibiotic antimicrobials in bacterial suspension tests were developed in the early twentieth century, standardized ways of evaluating the efficacy of antimicrobial dressings against microbial suspensions and biofilms are not available. Resistance to non-antibiotic antimicrobials and cross-resistance with antibiotics has been reported, but consensus on breakpoints is absent and surveillance is impossible. Antimicrobial stewardship is therefore in jeopardy. This review highlights these difficulties and in particular the efficacy of current non-antibiotic antimicrobials used in dressings, their efficacy, and the challenges of translating in vitro efficacy data to the efficacy of dressings in patients. This review calls for a unified approach to developing standardized methods of evaluating antimicrobial dressings that will provide an improved basis for practitioners to make informed choices in wound care.
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Affiliation(s)
- Jean-Yves Maillard
- School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, Wales, UK
| | - Günter Kampf
- Institute of Hygiene and Environmental Medicine, University of Greifswald, Germany
| | - Rose Cooper
- School of Sport & Health Sciences, Cardiff Metropolitan University, Cardiff, Wales, UK
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18
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Ren SY, Liu YS, Zhu GJ, Liu M, Shi SH, Ren XD, Hao YG, Gao RD. Strategies and challenges in the treatment of chronic venous leg ulcers. World J Clin Cases 2020; 8:5070-5085. [PMID: 33269244 DOI: 10.12998/wjcc.v8.i21.5070.pmid:] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2020] [Revised: 08/06/2020] [Accepted: 09/28/2020] [Indexed: 02/05/2023] Open
Abstract
Evaluating patients with chronic venous leg ulcers (CVLUs) is essential to find the underlying etiology. The basic tenets in managing CVLUs are to remove the etiological causes, to address systemic and metabolic conditions, to examine the ulcers and artery pulses, and to control wound infection with debridement and eliminating excessive pressure on the wound. The first-line treatments of CVLUs remain wound care, debridement, bed rest with leg elevation, and compression. Evidence to support the efficacy of silver-based dressings in healing CVLUs is unavailable. Hydrogen peroxide is harmful to the growth of granulation tissue in the wound. Surgery options include a high ligation with or without stripping or ablation of the GSVs depending on venous reflux or insufficiency. Yet, not all CVLUs are candidates for surgical treatment because of comorbidities. When standard care of wound for 4 wk failed to heal CVLUs effectively, use of advanced wound care should be considered based on the available evidence. Negative pressure wound therapy facilitates granulation tissue development, thereby helping closure of CVLUs. Autologous split-thickness skin grafting is still the gold standard approach to close huge CVLUs. Hair punch graft appears to have a better result than traditional hairless punch graft for CVLUs. Application of adipose tissue or placenta-derived mesenchymal stem cells is a promising therapy for wound healing. Autologous platelet-rich plasma provides an alternative strategy for surgery for safe and natural healing of the ulcer. The confirmative efficacy of current advanced ulcer therapies needs more robust evidence.
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Affiliation(s)
- Shi-Yan Ren
- Department of General Surgery and Vascular Surgery, Aviation General Hospital, China Medical University, Beijing 100012, China.
| | - Yong-Sheng Liu
- Department of Dermatology, Aviation General Hospital, Beijing 100012, China
| | - Guo-Jian Zhu
- Department of General Surgery, Taian Communications Hospital, Taian 271000, Shandong Province, China
| | - Meng Liu
- Department of Surgery, Tianjin Hexi Hospital, Tianjin 300202, Tianjin, China
| | - Shao-Hui Shi
- Department of Orthopaedic Surgery, Aviation General Hospital, China Medical University, Beijing 100012, China
| | - Xiao-Dong Ren
- Department of Surgery, Wanquanqu Zhongyi Hospital, Zhangjiakou 076250, Hebei Province, China
| | - Ya-Guang Hao
- Department of Medical Administrative, Aviation General Hospital, China Medical University, Beijing 100012, China
| | - Rong-Ding Gao
- Department of General Surgery, Aviation General Hospital, China Medical University, Beijing 100012, China
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19
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Ren SY, Liu YS, Zhu GJ, Liu M, Shi SH, Ren XD, Hao YG, Gao RD. Strategies and challenges in the treatment of chronic venous leg ulcers. World J Clin Cases 2020; 8:5070-5085. [PMID: 33269244 PMCID: PMC7674718 DOI: 10.12998/wjcc.v8.i21.5070] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2020] [Revised: 08/06/2020] [Accepted: 09/28/2020] [Indexed: 02/05/2023] Open
Abstract
Evaluating patients with chronic venous leg ulcers (CVLUs) is essential to find the underlying etiology. The basic tenets in managing CVLUs are to remove the etiological causes, to address systemic and metabolic conditions, to examine the ulcers and artery pulses, and to control wound infection with debridement and eliminating excessive pressure on the wound. The first-line treatments of CVLUs remain wound care, debridement, bed rest with leg elevation, and compression. Evidence to support the efficacy of silver-based dressings in healing CVLUs is unavailable. Hydrogen peroxide is harmful to the growth of granulation tissue in the wound. Surgery options include a high ligation with or without stripping or ablation of the GSVs depending on venous reflux or insufficiency. Yet, not all CVLUs are candidates for surgical treatment because of comorbidities. When standard care of wound for 4 wk failed to heal CVLUs effectively, use of advanced wound care should be considered based on the available evidence. Negative pressure wound therapy facilitates granulation tissue development, thereby helping closure of CVLUs. Autologous split-thickness skin grafting is still the gold standard approach to close huge CVLUs. Hair punch graft appears to have a better result than traditional hairless punch graft for CVLUs. Application of adipose tissue or placenta-derived mesenchymal stem cells is a promising therapy for wound healing. Autologous platelet-rich plasma provides an alternative strategy for surgery for safe and natural healing of the ulcer. The confirmative efficacy of current advanced ulcer therapies needs more robust evidence.
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Affiliation(s)
- Shi-Yan Ren
- Department of General Surgery and Vascular Surgery, Aviation General Hospital, China Medical University, Beijing 100012, China
| | - Yong-Sheng Liu
- Department of Dermatology, Aviation General Hospital, Beijing 100012, China
| | - Guo-Jian Zhu
- Department of General Surgery, Taian Communications Hospital, Taian 271000, Shandong Province, China
| | - Meng Liu
- Department of Surgery, Tianjin Hexi Hospital, Tianjin 300202, Tianjin, China
| | - Shao-Hui Shi
- Department of Orthopaedic Surgery, Aviation General Hospital, China Medical University, Beijing 100012, China
| | - Xiao-Dong Ren
- Department of Surgery, Wanquanqu Zhongyi Hospital, Zhangjiakou 076250, Hebei Province, China
| | - Ya-Guang Hao
- Department of Medical Administrative, Aviation General Hospital, China Medical University, Beijing 100012, China
| | - Rong-Ding Gao
- Department of General Surgery, Aviation General Hospital, China Medical University, Beijing 100012, China
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20
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Talapko J, Matijević T, Juzbašić M, Antolović-Požgain A, Škrlec I. Antibacterial Activity of Silver and Its Application in Dentistry, Cardiology and Dermatology. Microorganisms 2020; 8:1400. [PMID: 32932967 PMCID: PMC7565656 DOI: 10.3390/microorganisms8091400] [Citation(s) in RCA: 82] [Impact Index Per Article: 16.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2020] [Revised: 09/07/2020] [Accepted: 09/11/2020] [Indexed: 02/07/2023] Open
Abstract
The problem of antimicrobial resistance is increasingly present and requires the discovery of new antimicrobial agents. Although the healing features of silver have been recognized since ancient times, silver has not been used due to newly discovered antibiotics. Thanks to technology development, a significant step forward has been made in silver nanoparticles research. Nowadays, silver nanoparticles are a frequent target of researchers to find new and better drugs. Namely, there is a need for silver nanoparticles as alternative antibacterial nanobiotics. Silver nanoparticles (AgNPs), depending on their size and shape, also have different antimicrobial activity. In addition to their apparent antibacterial activity, AgNPs can serve as drug delivery systems and have anti-thrombogenic, anti-platelet, and anti-hypertensive properties. Today they are increasingly used in clinical medicine and dental medicine. This paper presents silver antimicrobial activity and its use in dentistry, cardiology, and dermatology, where it has an extensive range of effects.
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Affiliation(s)
- Jasminka Talapko
- Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, HR-31000 Osijek, Croatia; (J.T.); (M.J.)
| | - Tatjana Matijević
- Department of Dermatology and Venereology, Clinical Hospital Center Osijek, HR-31000 Osijek, Croatia;
| | - Martina Juzbašić
- Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, HR-31000 Osijek, Croatia; (J.T.); (M.J.)
| | - Arlen Antolović-Požgain
- Faculty of Medicine, Josip Juraj Strossmayer University of Osijek, HR-31000 Osijek, Croatia
- Department of Microbiology, Institute of Public Health Osijek, HR-31000 Osijek, Croatia
| | - Ivana Škrlec
- Faculty of Dental Medicine and Health, Josip Juraj Strossmayer University of Osijek, HR-31000 Osijek, Croatia; (J.T.); (M.J.)
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21
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Park I, Kim JY, Lee H, Park G, Park J, Hwang H, Yun S, Ohe H, Hong KP, Park JK, Jang JH, Yun SS. Draft Revision of Clinical Practice Guidelines for Varicose Veins -Treatment-. Phlebology 2020. [DOI: 10.37923/phle.2020.18.2.29] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Affiliation(s)
| | - Jang Yong Kim
- Division of Vascular and Transplant Surgery, Department of Surgery, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Korea
| | - Hogyun Lee
- Division of Vascular and Transplant Surgery, Department of Surgery, Chonnam National University Hospital, Gwangju, Korea
| | - Geunmyeong Park
- Division of Vascular and Transplant Surgery, Department of Surgery, Inha University Hospital, Inchon, Korea
| | - Junho Park
- Happy Varicose Vein Clinic, Seoul, Korea
| | - Hongpil Hwang
- Division of Vascular and Transplant Surgery, Department of Surgery, Jeonbuk National University Hospital, Jeonju, Korea
| | - Sangchul Yun
- Department of Surgery, Soonchunhyang University Seoul Hospital, Seoul, Korea
| | - Haengjin Ohe
- Division of Vascular and Transplant, Department of Surgery, Inje University Seoul Paik Hospital, Seoul, Korea
| | - Ki-Pyo Hong
- Department of Thoracic and Cardiovascular Surgery, National Health Insurance Service Ilsan Hospital, Goyang, Korea
| | - Jong Kwon Park
- Division of Vascular and Transplant, Department of Surgery, Inje University Haeundae Paik Hospital, Busan, Korea
| | | | - Sang Seob Yun
- Division of Vascular and Transplant Surgery, Department of Surgery, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Korea
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22
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Skin Wound Healing Process and New Emerging Technologies for Skin Wound Care and Regeneration. Pharmaceutics 2020; 12:pharmaceutics12080735. [PMID: 32764269 PMCID: PMC7463929 DOI: 10.3390/pharmaceutics12080735] [Citation(s) in RCA: 627] [Impact Index Per Article: 125.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2020] [Revised: 07/23/2020] [Accepted: 07/31/2020] [Indexed: 12/14/2022] Open
Abstract
Skin wound healing shows an extraordinary cellular function mechanism, unique in nature and involving the interaction of several cells, growth factors and cytokines. Physiological wound healing restores tissue integrity, but in many cases the process is limited to wound repair. Ongoing studies aim to obtain more effective wound therapies with the intention of reducing inpatient costs, providing long-term relief and effective scar healing. The main goal of this comprehensive review is to focus on the progress in wound medication and how it has evolved over the years. The main complications related to the healing process and the clinical management of chronic wounds are described in the review. Moreover, advanced treatment strategies for skin regeneration and experimental techniques for cellular engineering and skin tissue engineering are addressed. Emerging skin regeneration techniques involving scaffolds activated with growth factors, bioactive molecules and genetically modified cells are exploited to overcome wound healing technology limitations and to implement personalized therapy design.
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23
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Morilla‐Herrera JC, Morales‐Asencio JM, Gómez‐González AJ, Díez‐De Los Ríos A, Lupiáñez‐Pérez I, Acosta‐Andrade C, Aranda‐Gallardo M, Moya‐Suárez AB, Kaknani‐Uttumchandani S, García‐Mayor S. Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study). J Adv Nurs 2020; 76:2191-2197. [PMID: 32395842 PMCID: PMC7496185 DOI: 10.1111/jan.14412] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2019] [Revised: 03/09/2020] [Accepted: 04/28/2020] [Indexed: 01/08/2023]
Abstract
AIM To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact® ) against a silver dressing (Aquacel® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing. DESIGN Open randomized controlled trial, with blinded endpoint. METHODS Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks. DISCUSSION Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. IMPACT Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.
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Affiliation(s)
- Juan C. Morilla‐Herrera
- Department of NursingUniversity of Málaga, Faculty of Health SciencesMalagaSpain
- Distrito Sanitario Málaga – Valle del GuadalhorceMalagaSpain
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
| | - José M. Morales‐Asencio
- Department of NursingUniversity of Málaga, Faculty of Health SciencesMalagaSpain
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
| | | | | | - Inmaculada Lupiáñez‐Pérez
- Department of NursingUniversity of Málaga, Faculty of Health SciencesMalagaSpain
- Distrito Sanitario Málaga – Valle del GuadalhorceMalagaSpain
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
| | | | - Marta Aranda‐Gallardo
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
- Agencia Sanitaria Costa del SolMarbellaSpain
| | - Ana B. Moya‐Suárez
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
- Agencia Sanitaria Costa del SolMarbellaSpain
| | - Shakira Kaknani‐Uttumchandani
- Department of NursingUniversity of Málaga, Faculty of Health SciencesMalagaSpain
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
| | - Silvia García‐Mayor
- Department of NursingUniversity of Málaga, Faculty of Health SciencesMalagaSpain
- Instituto de Investigación Biomédica de Málaga (IBIMA)MalagaSpain
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24
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Rabe E, Partsch H, Morrison N, Meissner MH, Mosti G, Lattimer CR, Carpentier PH, Gaillard S, Jünger M, Urbanek T, Hafner J, Patel M, Wu S, Caprini J, Lurie F, Hirsch T. Risks and contraindications of medical compression treatment - A critical reappraisal. An international consensus statement. Phlebology 2020; 35:447-460. [PMID: 32122269 PMCID: PMC7383414 DOI: 10.1177/0268355520909066] [Citation(s) in RCA: 60] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
OBJECTIVES Medical compression therapy is used for non-invasive treatment of venous and lymphatic diseases. Medical compression therapy-associated adverse events and contraindications have been reported, although some contraindications are theoretically based. This consensus statement provides recommendations on medical compression therapy risks and contraindications. METHODS A systematic literature search of medical compression therapy publications reporting adverse events up until November 2017 was performed. A consensus panel comprising 15 international experts critically reviewed the publications and formulated the recommendations. RESULTS Sixty-two publications reporting medical compression therapy adverse events were identified. The consensus panel issued 21 recommendations on medical compression therapy contraindications and adverse event risk mitigation, in addition to reviewing medical compression therapy use in borderline indications. The most frequently reported non-severe medical compression therapy-associated adverse events included skin irritation, discomfort and pain. Very rare but severe adverse events, including soft tissue and nerve injury, were also identified. CONCLUSION This consensus statement summarises published medical compression therapy-associated adverse events and contraindications, and provides guidance on medical compression therapy. Severe medical compression therapy-associated adverse events are very rarely encountered if compression is used correctly and contraindications are considered.
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Affiliation(s)
- Eberhard Rabe
- Department of Dermatology, University of Bonn, Bonn, Germany
| | - Hugo Partsch
- Department of Dermatology, Medical University of Vienna, Vienna, Austria
| | | | - Mark H Meissner
- Department of Surgery, Harborview Medical Center, Seattle, WA, USA
| | - Giovanni Mosti
- Angiology Department, Clinica MD Barbantini, Lucca, Italy
| | - Christopher R Lattimer
- Josef Pflug Vascular Laboratory, West London Vascular and Interventional Centre, Ealing Hospital & Imperial College, London, UK
| | - Patrick H Carpentier
- Centre de Recherche Universitaire de La Léchère, Equipe THEMAS, Université Joseph Fourier, Grenoble, France
| | | | - Michael Jünger
- Department of Dermatology, University of Greifswald, Greifswald, Germany
| | - Tomasz Urbanek
- Department of General Surgery, Vascular Surgery, Angiology and Phlebology, Medical University of Silesia, Katowice, Poland
| | - Juerg Hafner
- Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland
| | - Malay Patel
- First Choice Vascular, Swastik Society, Ahmedabad, India
| | - Stephanie Wu
- Department of Podiatric Surgery & Applied Biomechanics, Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA
| | - Joseph Caprini
- Department of Vascular Surgery, The University of Chicago, Chicago, IL, USA
| | - Fedor Lurie
- Department of Vascular Surgery, University of Michigan, Ann Arbor, MI, USA
| | - Tobias Hirsch
- Practice for Internal Medicine and Vascular Diseases, Halle, Germany
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25
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Reina-Bueno M, Palomo-Toucedo IC, Castro-Méndez A, Domínguez-Maldonado G, Vázquez-Bautista MDC. Methicillin-Resistant Staphylococcus aureus Diabetic Foot Crossed Infection: A Case Report. Pathogens 2020; 9:E549. [PMID: 32650481 PMCID: PMC7400664 DOI: 10.3390/pathogens9070549] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2020] [Revised: 07/05/2020] [Accepted: 07/06/2020] [Indexed: 01/22/2023] Open
Abstract
This work presents a protocol to prevent the transmission of multidrug-resistant infections. We focus on the Diabetic Foot Unit Podiatry Clinic Area attached to the University of Seville in particular. The most common complication for patients with diabetes is leg ulcers. Together with neuropathy, vasculopathy, and immunological response disorder, these individuals have a high predisposition to developing infections. Staphylococcus aureus is a highly prevalent microorganism in humans which, at times, may act as a pathogen. Due mainly to indiscriminate abuse of antibiotics, the methicillin-resistant strain known by its initials as MRSA is the most extended nosocomial infection globally and is a severe community and hospital healthcare problem. This paper describes compliance with new general recommendations on cleaning, hygiene, and decontamination, in addition to implementation of this specific protocol, after detection of cross infection (healthcare-related infection) in the studied unit in two patients with MRSA-infected ulcers. After an in-depth bibliographical review, strict hand hygiene measures and use of non-sterile gloves were used when treating all patients with a diabetic foot. Finally, we reflect on the need to educate healthcare personnel to guarantee correct prescription of selected antibiotics. The role of the podiatrist in the multidisciplinary team is highlighted not only in terms of management and treatment of lesions in diabetic patients, but also as a healthcare agent for the detection and prevention of MRSA together with other multidrug-resistant infections.
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Affiliation(s)
- María Reina-Bueno
- Department of Podiatry, University of Seville, 41009 Seville, Spain; (I.C.P.-T.); (A.C.-M.); (G.D.-M.); (M.d.C.V.-B.)
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26
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Duckworth PF, Maddocks SE, Rahatekar SS, Barbour ME. Alginate films augmented with chlorhexidine hexametaphosphate particles provide sustained antimicrobial properties for application in wound care. JOURNAL OF MATERIALS SCIENCE. MATERIALS IN MEDICINE 2020; 31:33. [PMID: 32162052 PMCID: PMC7066275 DOI: 10.1007/s10856-020-06370-0] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 09/11/2019] [Accepted: 02/21/2020] [Indexed: 06/10/2023]
Abstract
All chronic wounds are colonised by bacteria; for some, colonisation progresses to become infection. Alginate wound dressings are used for highly exuding chronic wounds as they are very absorbent, taking up large quantities of exudate while maintaining a moist wound bed to support healing. Some alginate dressings are doped with antimicrobials, most commonly silver, but evidence regarding the efficacy of these is largely inconclusive. This manuscript describes the development and in vitro assessment of alginate materials doped with chlorhexidine hexametaphosphate (CHX-HMP), a sparingly soluble salt which when exposed to aqueous environments provides sustained release of the common antiseptic chlorhexidine. Comparator materials were a commercial silver alginate dressing material and an alginate doped with chlorhexidine digluconate (CHXdg). CHX-HMP alginates provided a dose-dependent CHX release which was sustained for over 14 days, whereas CHXdg alginates released limited CHX and this ceased within 24 h. CHX-HMP and silver alginates were efficacious against 5 major wound pathogens (MRSA, E. coli, P. aeruginosa, K. pneumoniae, A. baumannii) in a total viable count (TVC) and an agar diffusion zone of inhibition (ZOI) model. At baseline the silver alginate was more effective than the CHX-HMP alginate in the TVC assay but the CHX-HMP alginate was the more effective in the ZOI assay. After 7 days' artificial aging the CHX-HMP alginate was more effective than the silver alginate for four of the five bacteria tested in both assays. These materials may ultimately find application in the development of wound dressings for chronic wounds that provide sustained antimicrobial protection.
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Affiliation(s)
- Peter F Duckworth
- Oral Nanoscience, Bristol Dental School, University of Bristol, Bristol, UK
- ACCIS, Queens School of Engineering, University of Bristol, Bristol, UK
| | - Sarah E Maddocks
- Cardiff School of Health Sciences, Cardiff Metropolitan University, Cardiff, UK
| | - Sameer S Rahatekar
- School of Aerospace, Transport and Manufacturing, University of Cranfield, Bedford, UK
| | - Michele E Barbour
- Oral Nanoscience, Bristol Dental School, University of Bristol, Bristol, UK.
- Pertinax Pharma Ltd, Bristol, UK.
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27
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Majtan J, Sojka M, Palenikova H, Bucekova M, Majtan V. Vitamin C Enhances the Antibacterial Activity of Honey against Planktonic and Biofilm-Embedded Bacteria. Molecules 2020; 25:molecules25040992. [PMID: 32102181 PMCID: PMC7070301 DOI: 10.3390/molecules25040992] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2020] [Revised: 02/18/2020] [Accepted: 02/22/2020] [Indexed: 12/20/2022] Open
Abstract
Multifactorial antibacterial action is an important feature of honey; however, its bactericidal efficacy against biofilm-embedded bacteria is limited. The aim of this study was to investigate the impact of vitamin C (Vit C) on the antibacterial activity of natural honeys against planktonic as well as biofilm-embedded bacterial pathogens. The antibacterial activity of four honey samples supplemented with Vit C was expressed as the minimum inhibitory concentration (MIC). At sub-MICs, Vit C significantly increased the antibacterial activity of the tested honeys against Pseudomonas aeruginosa in planktonic cultures. However, after supplementation, honeydew honey, the most active honey, was ineffective against Staphylococcus aureus. On the other hand, when 100% honeydew honey was supplemented with Vit C (100 mg/g of honey) in a multispecies wound biofilm model, complete eradication of almost all bacterial isolates, including S. aureus, was observed. Furthermore, a mixture of honey and Vit C was partially effective against Enterococcus faecalis, whereas honey alone exhibited no antibacterial activity against this bacterium. Vit C counteracted hydrogen peroxide in honey solution and, thus, eliminated the major antibacterial compound present in honey. It is likely that a combination of honey with Vit C may trigger the intracellular production of reactive oxygen species in bacterial cells, but the exact cellular mechanisms warrant further investigations.
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Affiliation(s)
- Juraj Majtan
- Laboratory of Apidology and Apitherapy, Department of Microbial Genetics, Institute of Molecular Biology, Slovak Academy of Sciences, Dubravska cesta 21, 845 51 Bratislava, Slovakia; (H.P.); (M.B.)
- Correspondence: ; Tel.: +421-903-869413
| | - Martin Sojka
- Department of Microbiology, Faculty of Medicine, Slovak Medical University, Limbova 12, 833 03 Bratislava, Slovakia; (M.S.); (V.M.)
- Regional Health Public Authority, Medercska 39, 945 75 Komarno, Slovakia
| | - Helena Palenikova
- Laboratory of Apidology and Apitherapy, Department of Microbial Genetics, Institute of Molecular Biology, Slovak Academy of Sciences, Dubravska cesta 21, 845 51 Bratislava, Slovakia; (H.P.); (M.B.)
| | - Marcela Bucekova
- Laboratory of Apidology and Apitherapy, Department of Microbial Genetics, Institute of Molecular Biology, Slovak Academy of Sciences, Dubravska cesta 21, 845 51 Bratislava, Slovakia; (H.P.); (M.B.)
- Protein Science Lab, Department of Biological Sciences, University of Singapore, Singapore 119077, Singapore
| | - Viktor Majtan
- Department of Microbiology, Faculty of Medicine, Slovak Medical University, Limbova 12, 833 03 Bratislava, Slovakia; (M.S.); (V.M.)
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28
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Chatterjee S, Sen S, Hazra A, Das AK. Randomized controlled trial of topical mupirocin versus mupirocin with sucralfate combination in chronic skin ulcers. Indian J Pharmacol 2019; 51:316-322. [PMID: 31831920 PMCID: PMC6892012 DOI: 10.4103/ijp.ijp_237_17] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2017] [Revised: 10/16/2019] [Accepted: 10/21/2019] [Indexed: 01/22/2023] Open
Abstract
OBJECTIVES: The objective of this study was to carry out a head-to-head comparison of topical sucralfate combined with mupirocin versus mupirocin alone in the treatment of chronic skin ulcers with respect to both effectiveness and safety. MATERIALS AND METHODS: A parallel-group, open-label, randomized, controlled trial (CTRI/2015/12/006443) was carried out with patients suffering from skin ulcers of Wagner grading 1 or 2 persisting for over 4 weeks. Ninety-six patients were recruited in total, and the modified intention-to-treat analysis dataset included 44 participants treated with mupirocin 2% and 46 treated with combined mupirocin 2% and sucralfate 7% ointment. Both medications were applied topically thrice daily for 6 weeks. Ulcer area assessed using millimeter graph paper and wound infection score assessed on a three-point scale were effectiveness measures. Treatment-emergent adverse reactions that were reported by patients or observed by the investigators were recorded. RESULTS: The median ulcer area was significantly reduced in the combined treatment group at the end of treatment. Clinically, 41.3% of the participants in the combined group showed complete ulcer healing at 6 weeks compared to 18.18% in the mupirocin alone group (P = 0.022). The wound infection score declined significantly from baseline by the end of 3 weeks of treatment in both the groups. The frequency of qualitative wound attributes, namely pain, discharge, and erythema, remained comparable between the groups except for discharge which disappeared completely from all remaining ulcers in the combined group but was still present in 11.36% of the participants treated with mupirocin alone (P = 0.025) at 6 weeks. Adverse events were few, all local, mild, and tolerable. CONCLUSIONS: The wound healing effect of topical sucralfate adds to the antimicrobial effect of mupirocin toward the overall improvement of chronic skin ulcers. The effect of combined topical treatment needs comparison with other topical medications and wound healing strategies.
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Affiliation(s)
- Subhrangsu Chatterjee
- Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
| | - Sumit Sen
- Department of Dermatology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
| | - Avijit Hazra
- Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
| | - Amal Kanti Das
- Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
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29
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Jiménez-García JF, Aguilera-Manrique G, Arboledas-Bellón J, Gutiérrez-García M, González-Jiménez F, Lafuente-Robles N, Parra-Anguita L, García-Fernández FP. The Effectiveness of Advanced Practice Nurses with Respect to Complex Chronic Wounds in the Management of Venous Ulcers. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2019; 16:E5037. [PMID: 31835653 PMCID: PMC6950269 DOI: 10.3390/ijerph16245037] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/17/2019] [Revised: 12/05/2019] [Accepted: 12/09/2019] [Indexed: 11/25/2022]
Abstract
This study aims to evaluate the effectiveness of advanced practice nurses with respect to complex chronic wounds (APN-CCWs) in the care of patients with venous ulcers. A multicentric, quasi-experimental pre-post study was conducted without a control group in the sanitary management areas where the APN-CCW program is being piloted. The intervention consisted of a mass training of clinical nurses from the participating districts on the proper management of injuries and the use of compression therapy. The data were collected through a specifically constructed questionnaire with questions regarding descriptive variables of injuries and their treatment. A total of 643 professionals responded (response rate of 89.1%), attending to a total population of 707,814 inhabitants. An increase in multilayer bandage use by 15.67%, an increase in elastic bandage use by 13.24%, and a significant decrease in the referral of patients to consultation with hospital specialists was achieved, from 21.08% to 12.34%. The number of patients referred to the APNs was 13.25%, which implied a resolution rate of 94.08% of their injuries. In conclusion, the coordination by the APN-CCWs in patients with venous ulcers was effective in improving the continuity of care, in the optimization of resources, and in their care role.
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Affiliation(s)
- Juan Francisco Jiménez-García
- Advanced Practice Nurse in Complex Chronic Wound, Sanitary District Poniente of Almería, 04746 Venta del Viso, Spain
| | - Gabriel Aguilera-Manrique
- Nursing Department, Dean of the Faculty of Health Sciences, University of Almería, 04120 Almería, Spain;
| | - Josefina Arboledas-Bellón
- Advanced Practice Nurse in Complex Chronic Wound, Sanitary District Jaén Northeast, 23400 Úbeda, Spain;
| | - María Gutiérrez-García
- Advanced Practice Nurse in Complex Chronic Wound, Sanitary District Serrania of Malaga, 29400 Ronda, Spain;
| | - Francisco González-Jiménez
- Advanced Practice Nurse in Complex Chronic Wound, Sanitary District Metropolitano of Granada, 18016 Granada, Spain;
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30
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de Oliveira BGRB, de Oliveira FP, Teixeira LA, de Paula GR, de Oliveira BC, Pires BMFB. Epidermal growth factor vs platelet-rich plasma: Activity against chronic wound microbiota. Int Wound J 2019; 16:1408-1415. [PMID: 31571388 PMCID: PMC7949375 DOI: 10.1111/iwj.13205] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2019] [Revised: 08/05/2019] [Accepted: 08/11/2019] [Indexed: 01/09/2023] Open
Abstract
The objective was to evaluate Staphylococcus aureus and Pseudomonas aeruginosa colonisation of wounds treated with recombinant epidermal growth factor (EGF) and platelet-rich plasma (PRP); to analyse the susceptibility profiles of S. aureus and P. aeruginosa isolates from wounds treated with EGF and PRP; and to describe the presence of infection in EGF-treated and PRP-treated wounds. Experimental study was performed using clinical specimens collected with swabs. Patients were treated with PRP and EGF in the outpatient clinic of a university hospital. Forty-three isolates were obtained from 31 patients, 41.9% (13/31) of whom had been treated with EGF and 58.0% (18/31) with PRP. Ten of the 43 isolates were identified as S. aureus, 60.0% (6/10) of which were isolated from PRP-treated wounds. Among the 33 P. aeruginosa isolates, 66.6% (22/33) were isolated from PRP-treated wounds. Regarding antimicrobial susceptibility, only one strain isolated from an EGF-treated wound was identified as methicillin-resistant S. aureus (MRSA). Among the P. aeruginosa isolates, one obtained from a patient treated with EGF was multidrug-resistant. Patients treated with EGF had no infections during the follow-up period, and there was a significant difference between the 1st and 12th week in wound infection improvement in patients treated with PRP (P = .0078).
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31
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Malone M, Schwarzer S, Radzieta M, Jeffries T, Walsh A, Dickson HG, Micali G, Jensen SO. Effect on total microbial load and community composition with two vs six-week topical Cadexomer Iodine for treating chronic biofilm infections in diabetic foot ulcers. Int Wound J 2019; 16:1477-1486. [PMID: 31487117 DOI: 10.1111/iwj.13219] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/10/2019] [Revised: 08/18/2019] [Accepted: 08/21/2019] [Indexed: 12/13/2022] Open
Abstract
This study compares two vs six weeks of topical antimicrobial therapy with Cadexomer Iodine in patients with diabetic foot ulcers (DFUs) complicated by chronic biofilm infections. Patients with non-healing DFUs with suspected chronic biofilm infections were eligible for enrolment. Patients were randomised to receive either two or six weeks of treatment with topical Cadexomer Iodine. Tissue biopsies from the ulcers were obtained pre-and-post treatment and underwent DNA sequencing and real-time quantitative polymerase chain reaction (PCR) to determine the total microbial load, community composition, and diversity of bacteria. Scanning electron microscopy confirmed biofilm in all 18 ulcers with suspected chronic biofilm infections. Cadexomer Iodine resulted in 14 of 18 (78%) samples achieving a mean 0.5 log10 reduction in microbial load. Regardless of treatment duration, there was no statistical difference in the reduction of total microbial loads. No difference in the rate of wound healing in the two groups was seen at 6 weeks. Cadexomer Iodine reduces the total microbial load in DFUs with chronic biofilm infections and affects microbial community composition and diversity. All ulcers in both groups showed an initial reduction in wound size with application of Cadexomer Iodine, which might reflect its effect on biofilms.
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Affiliation(s)
- Matthew Malone
- South West Sydney Limb Preservation and Wound Research, South West Sydney Local Health District, Sydney, New South Wales, Australia.,High Risk Foot Service, Liverpool Hospital, South West Sydney LHD, Sydney, New South Wales, Australia.,Infectious Diseases and Microbiology, School of Medicine, Western Sydney University, Sydney, New South Wales, Australia
| | - Saskia Schwarzer
- South West Sydney Limb Preservation and Wound Research, South West Sydney Local Health District, Sydney, New South Wales, Australia.,High Risk Foot Service, Liverpool Hospital, South West Sydney LHD, Sydney, New South Wales, Australia
| | - Michael Radzieta
- South West Sydney Limb Preservation and Wound Research, South West Sydney Local Health District, Sydney, New South Wales, Australia.,Infectious Diseases and Microbiology, School of Medicine, Western Sydney University, Sydney, New South Wales, Australia
| | - Thomas Jeffries
- Infectious Diseases and Microbiology, School of Medicine, Western Sydney University, Sydney, New South Wales, Australia
| | - Annie Walsh
- South West Sydney Limb Preservation and Wound Research, South West Sydney Local Health District, Sydney, New South Wales, Australia.,High Risk Foot Service, Liverpool Hospital, South West Sydney LHD, Sydney, New South Wales, Australia
| | - Hugh G Dickson
- South West Sydney Limb Preservation and Wound Research, South West Sydney Local Health District, Sydney, New South Wales, Australia
| | - Grace Micali
- Antimicrobial Resistance and Mobile Elements Group, Ingham Institute of Applied Medical Research, Sydney, New South Wales, Australia
| | - Slade O Jensen
- South West Sydney Limb Preservation and Wound Research, South West Sydney Local Health District, Sydney, New South Wales, Australia.,Infectious Diseases and Microbiology, School of Medicine, Western Sydney University, Sydney, New South Wales, Australia.,Antimicrobial Resistance and Mobile Elements Group, Ingham Institute of Applied Medical Research, Sydney, New South Wales, Australia
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32
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Leonel C, Sena IFG, Silva WN, Prazeres PHDM, Fernandes GR, Mancha Agresti P, Martins Drumond M, Mintz A, Azevedo VAC, Birbrair A. Staphylococcus epidermidis role in the skin microenvironment. J Cell Mol Med 2019; 23:5949-5955. [PMID: 31278859 PMCID: PMC6714221 DOI: 10.1111/jcmm.14415] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2019] [Revised: 04/12/2019] [Accepted: 04/30/2019] [Indexed: 02/06/2023] Open
Abstract
Wound healing is a complex dynamic physiological process in response to cutaneous destructive stimuli that aims to restore the cutaneous' barrier role. Deciphering the underlying mechanistic details that contribute to wound healing will create novel therapeutic strategies for skin repair. Recently, by using state-of-the-art technologies, it was revealed that the cutaneous microbiota interact with skin immune cells. Strikingly, commensal Staphylococcus epidermidis-induced CD8+ T cells induce re-epithelization of the skin after injury, accelerating wound closure. From a drug development perspective, the microbiota may provide new therapeutic candidate molecules to accelerate skin healing. Here, we summarize and evaluate recent advances in the understanding of the microbiota in the skin microenvironment.
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Affiliation(s)
- Caroline Leonel
- Departamento de PatologiaUniversidade Federal de Minas GeraisBelo HorizonteBrasil
| | - Isadora F. G. Sena
- Departamento de PatologiaUniversidade Federal de Minas GeraisBelo HorizonteBrasil
| | - Walison N. Silva
- Departamento de PatologiaUniversidade Federal de Minas GeraisBelo HorizonteBrasil
| | | | | | - Pamela Mancha Agresti
- Departamento de Biologia GeralUniversidade Federal de Minas GeraisBelo HorizonteBrasil
| | | | - Akiva Mintz
- Department of RadiologyColumbia University Medical CenterNew YorkNew York
| | - Vasco A. C. Azevedo
- Departamento de Biologia GeralUniversidade Federal de Minas GeraisBelo HorizonteBrasil
| | - Alexander Birbrair
- Departamento de PatologiaUniversidade Federal de Minas GeraisBelo HorizonteBrasil
- Department of RadiologyColumbia University Medical CenterNew YorkNew York
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33
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Khansa I, Schoenbrunner AR, Kraft CT, Janis JE. Silver in Wound Care-Friend or Foe?: A Comprehensive Review. PLASTIC AND RECONSTRUCTIVE SURGERY-GLOBAL OPEN 2019; 7:e2390. [PMID: 31592393 PMCID: PMC6756674 DOI: 10.1097/gox.0000000000002390] [Citation(s) in RCA: 99] [Impact Index Per Article: 16.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2019] [Accepted: 06/19/2019] [Indexed: 12/12/2022]
Abstract
Due to its strong antimicrobial activity, silver is a commonly used adjunct in wound care. However, it also has the potential to impair healing by exerting toxic effects on keratinocytes and fibroblasts. The published literature on the use of silver in wound care is very heterogeneous, making it difficult to generate useful treatment guidelines. METHODS A search of high-quality studies on the use of silver in wound care was performed on PubMed. A detailed qualitative analysis of published articles was performed to evaluate the evidence for the use of silver in infected wounds, clean wounds, burns, and over closed surgical incisions. RESULTS Fifty-nine studies were included in this qualitative analysis. We found that, overall, the quality of the published research on silver is poor. While there is some evidence for short-term use of dressings containing nanocrystalline silver in infected wounds, the use of silver-containing dressings in clean wounds and over closed surgical incisions is not indicated. Negative-pressure wound therapy accelerates the healing of contaminated wounds, especially when silver is used as an adjunct. For burns, silver sulfadiazine slows healing and should not be used. Instead, nanocrystalline silver, or alternatives such as octenidine and polyhexanide, lead to less infection and faster healing. CONCLUSIONS In infected wounds, silver is beneficial for the first few days/weeks, after which nonsilver dressings should be used instead. For clean wounds and closed surgical incisions, silver confers no benefit. The ideal silver formulations are nanocrystalline silver and silver-coated polyurethane sponge for negative-pressure wound therapy. Silver sulfadiazine impairs wound healing. Proper use of silver-containing dressings is essential to optimize wound healing.
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Affiliation(s)
- Ibrahim Khansa
- From the Division of Plastic and Reconstructive Surgery, Nationwide Children’s Hospital, Columbus, Ohio
- Department of Plastic and Reconstructive Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio
| | - Anna R. Schoenbrunner
- Department of Plastic and Reconstructive Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio
| | - Casey T. Kraft
- Department of Plastic and Reconstructive Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio
| | - Jeffrey E. Janis
- Department of Plastic and Reconstructive Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio
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Colenci R, Abbade LPF. Fundamental aspects of the local approach to cutaneous ulcers. An Bras Dermatol 2019; 93:859-870. [PMID: 30484531 PMCID: PMC6256234 DOI: 10.1590/abd1806-4841.20187812] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/03/2017] [Accepted: 03/31/2018] [Indexed: 01/13/2023] Open
Abstract
Ulcers or wounds can be classified as acute or chronic. Their treatment involves overall assessment of the patient and choice of suitable local therapy, and the appropriate indication and use of products. Technological progress in the field of wound treatment has increased rapidly. Constant updating, with emphasis on available scientific evidence, is necessary to offer the best approaches to patients with acute and chronic wounds. A qualitative analysis of literature was conducted to identify scientific publications that update the concepts involved in local wound treatment, to present some resources that can aid the healing process and describe the different types of dressings available. This review includes wound assessment using the acronym TIME (tissue, infection/inflammation, moisture balance and edge of wound), cleaning and debridement, infection/inflammation control, exudate control, dressing types and main indications.
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Affiliation(s)
- Raquel Colenci
- Technical Section of Nursing in Dermatology, Hospital das
Clínicas, Faculdade de Medicina de Botucatu, Universidade Estadual Paulista,
Botucatu (SP), Brazil
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Woodmansey EJ, Roberts CD. Appropriate use of dressings containing nanocrystalline silver to support antimicrobial stewardship in wounds. Int Wound J 2018; 15:1025-1032. [PMID: 30117675 PMCID: PMC7949668 DOI: 10.1111/iwj.12969] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2018] [Revised: 06/18/2018] [Accepted: 06/24/2018] [Indexed: 12/16/2022] Open
Abstract
Antimicrobial resistance is an ever-increasing global concern, with the era of untreatable infection becoming a reality. Wound care is no exception, with increasing issues of antibiotic-resistant infections across different wound types and care settings. Antibiotic resistance and stewardship have been the priority for most strategic interventions so far; however, in wound care, alternative or supplementary strategies using antiseptics should be considered. Antiseptics such as silver can provide effective cidal activity across a broad range of wound pathogens, assuming they are used at the correct level for an appropriate duration. Evidence summarised in this manuscript suggests that effective antiseptics, such as nanocrystalline silver, have an increasing body of evidence in support of their use to minimise transmission of antibiotic-resistant organisms as part of institutional infection control procedures and, in addition, through appropriate early use and stewardship on local wound infections, in conjunction with local procedures, to minimise the need for systemic antibiotic therapy. Engagement, alignment, and collaboration between wound care professionals and wider related teams and governments on antimicrobial stewardship, and the potential role of antiseptics within this, will help to generate further evidence for such interventions in the fight against antimicrobial-resistant infections in wound care.
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Affiliation(s)
- Emma J. Woodmansey
- Clinical Scientific and Medical AffairsSmith & Nephew Advanced Wound ManagementHullUK
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The Management of Critically Colonized and Locally Infected Leg Ulcers with an Acid-Oxidizing Solution: A Pilot Study. Adv Skin Wound Care 2018; 31:163-171. [PMID: 29561341 PMCID: PMC5895123 DOI: 10.1097/01.asw.0000530687.23867.bd] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
OBJECTIVE: Critical colonization or local infection is very common in chronic wounds, but clinically problematic. Because therapeutic options for these conditions are limited in number and efficacy, the study authors tested a new acid-oxidizing solution (AOS [Nexodyn]; APR Applied Pharma Research S.A., Balerna, Switzerland) to determine its ancillary antimicrobial properties and potential support for wound healing. DESIGN AND SETTING: This open-label clinical case series was conducted with a prospective, single-arm design at the Federal County Hospital in Bregenz, Austria. PATIENTS: In the study, 30 patients with critically colonized or locally infected chronic leg ulcers of any origin were included. INTERVENTIONS: The AOS was applied on each leg ulcer at every dressing change for 35 days. MAIN OUTCOME MEASURES: The tolerability and performance of the AOS were assessed by evaluating the ulcer characteristics and comparing them with those at baseline. The clinical course of wounds was analyzed using standard measures for bioburden, local infection, pain, pH, and wound healing. MAIN RESULTS: Application of the solution was well tolerated, and no adverse events were recorded. In all patients, local infection was overcome, and wound bed pH and wound area decreased significantly. In addition, patient pain levels decreased to a level where interventions were not required after study day 7. In 37% of all patients, a complete resolution of chronic ulcers was achieved by the end of the study period. CONCLUSION: According to these results, the AOS seems to be a valid and highly tolerable treatment to support wound healing in locally infected ulcers. Nevertheless, larger controlled cohort studies are needed to substantiate these findings.
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Díaz-Roa A, Patarroyo MA, Bello FJ, Da Silva PI. Sarconesin: Sarconesiopsis magellanica Blowfly Larval Excretions and Secretions With Antibacterial Properties. Front Microbiol 2018; 9:2249. [PMID: 30323791 PMCID: PMC6172317 DOI: 10.3389/fmicb.2018.02249] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2018] [Accepted: 09/03/2018] [Indexed: 10/28/2022] Open
Abstract
Larval therapy (LT) is an alternative treatment for healing chronic wounds; its action is based on debridement, the removal of bacteria, and stimulating granulation tissue. The most important mechanism when using LT for combating infection depends on larval excretions and secretions (ES). Larvae are protected against infection by a spectrum of antimicrobial peptides (AMPs); special interest in AMPs has also risen regarding understanding their role in wound healing since they degrade necrotic tissue and kill different bacteria during LT. Sarconesiopsis magellanica (Diptera: Calliphoridae) is a promising medically-important necrophagous fly. This article reports a small AMP being isolated from S. magellanica ES products for the first time; these products were obtained from third-instar larvae taken from a previously-established colony. ES were fractionated by RP-HPLC using C18 columns for the first analysis; the products were then lyophilised and their antimicrobial activity was characterized by incubation with different bacterial strains. These fractions' primary sequences were determined by mass spectrometry and de novo sequencing; five AMPs were obtained, the Sarconesin fraction was characterized and antibacterial activity was tested in different concentrations with minimum inhibitory concentrations starting at 1.2 μM. Potent inhibitory activity was shown against Gram-negative (Escherichia coli D31, E. coli DH5α, Salmonella enterica ATCC 13314, Pseudomonas aeruginosa 27853) and Gram-positive (Staphylococcus aureus ATCC 29213, S. epidermidis ATCC 12228, Micrococcus luteus A270) bacteria. Sarconesin has a significant similarity with Rho-family GTPases which are important in organelle development, cytoskeletal dynamics, cell movement, and wound repair. The data reported here indicated that Sarconesin could be an alternative candidate for use in therapeutics against Gram-negative and Gram-positive bacterial infections. Our study describes one peptide responsible for antibacterial activity when LT is being used. The results shown here support carrying out further experiments aimed at validating S. magellanica AMPs as novel resources for combating antibacterial resistance.
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Affiliation(s)
- Andrea Díaz-Roa
- Laboratório Especial de Toxinologia Aplicada, Instituto Butantan, São Paulo, Brazil.,PhD Programme in Biomedical and Biological Sciences, Universidad del Rosario, Bogotá, Colombia.,Biomedical Sciences Institute, Universidade de São Paulo, São Paulo, Brazil
| | - Manuel A Patarroyo
- Molecular Biology and Immunology Department, Fundación Instituto de Inmunología de Colombia, Bogotá, Colombia.,Basic Sciences Department, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia
| | - Felio J Bello
- Faculty of Agricultural and Livestock Sciences, Program of Veterinary Medicine, Universidad de La Salle, Bogotá, Colombia.,Medicine Faculty, Universidad Antonio Nariño, Bogotá, Colombia
| | - Pedro I Da Silva
- Laboratório Especial de Toxinologia Aplicada, Instituto Butantan, São Paulo, Brazil.,Biomedical Sciences Institute, Universidade de São Paulo, São Paulo, Brazil
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Westby MJ, Dumville JC, Stubbs N, Norman G, Wong JKF, Cullum N, Riley RD, Cochrane Wounds Group. Protease activity as a prognostic factor for wound healing in venous leg ulcers. Cochrane Database Syst Rev 2018; 9:CD012841. [PMID: 30171767 PMCID: PMC6513613 DOI: 10.1002/14651858.cd012841.pub2] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
BACKGROUND Venous leg ulcers (VLUs) are a common type of complex wound that have a negative impact on people's lives and incur high costs for health services and society. It has been suggested that prolonged high levels of protease activity in the later stages of the healing of chronic wounds may be associated with delayed healing. Protease modulating treatments have been developed which seek to modulate protease activity and thereby promote healing in chronic wounds. OBJECTIVES To determine whether protease activity is an independent prognostic factor for the healing of venous leg ulcers. SEARCH METHODS In February 2018, we searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase and CINAHL. SELECTION CRITERIA We included prospective and retrospective longitudinal studies with any follow-up period that recruited people with VLUs and investigated whether protease activity in wound fluid was associated with future healing of VLUs. We included randomised controlled trials (RCTs) analysed as cohort studies, provided interventions were taken into account in the analysis, and case-control studies if there were no available cohort studies. We also included prediction model studies provided they reported separately associations of individual prognostic factors (protease activity) with healing. Studies of any type of protease or combination of proteases were eligible, including proteases from bacteria, and the prognostic factor could be examined as a continuous or categorical variable; any cut-off point was permitted. The primary outcomes were time to healing (survival analysis) and the proportion of people with ulcers completely healed; the secondary outcome was change in ulcer size/rate of wound closure. We extracted unadjusted (simple) and adjusted (multivariable) associations between the prognostic factor and healing. DATA COLLECTION AND ANALYSIS Two review authors independently assessed studies for inclusion at each stage, and undertook data extraction, assessment of risk of bias and GRADE assessment. We collected association statistics where available. No study reported adjusted analyses: instead we collected unadjusted results or calculated association measures from raw data. We calculated risk ratios when both outcome and prognostic factor were dichotomous variables. When the prognostic factor was reported as continuous data and healing outcomes were dichotomous, we either performed regression analysis or analysed the impact of healing on protease levels, analysing as the standardised mean difference. When both prognostic factor and outcome were continuous data, we reported correlation coefficients or calculated them from individual participant data.We displayed all results on forest plots to give an overall visual representation. We planned to conduct meta-analyses where this was appropriate, otherwise we summarised narratively. MAIN RESULTS We included 19 studies comprising 21 cohorts involving 646 participants. Only 11 studies (13 cohorts, 522 participants) had data available for analysis. Of these, five were prospective cohort studies, four were RCTs and two had a type of case-control design. Follow-up time ranged from four to 36 weeks. Studies covered 10 different matrix metalloproteases (MMPs) and two serine proteases (human neutrophil elastase and urokinase-type plasminogen activators). Two studies recorded complete healing as an outcome; other studies recorded partial healing measures. There was clinical and methodological heterogeneity across studies; for example, in the definition of healing, the type of protease and its measurement, the distribution of active and bound protease species, the types of treatment and the reporting of results. Therefore, meta-analysis was not performed. No study had conducted multivariable analyses and all included evidence was of very low certainty because of the lack of adjustment for confounders, the high risk of bias for all studies except one, imprecision around the measures of association and inconsistency in the direction of association. Collectively the research indicated complete uncertainty as to the association between protease activity and VLU healing. AUTHORS' CONCLUSIONS This review identified very low validity evidence regarding any association between protease activity and VLU healing and there is complete uncertainty regarding the relationship. The review offers information for both future research and systematic review methodology.
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Affiliation(s)
- Maggie J Westby
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
| | - Jo C Dumville
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
| | - Nikki Stubbs
- St Mary's HospitalLeeds Community Healthcare NHS Trust3 Greenhill RoadLeedsUKLS12 3QE
| | - Gill Norman
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
| | - Jason KF Wong
- Manchester University NHS Foundation TrustManchester Centre for Plastic Surgery and Burns, Wythenshawe HospitalSouthmoor Road, WythenshaweManchesterUKM23 9LT
| | - Nicky Cullum
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
| | - Richard D Riley
- Keele UniversityResearch Institute for Primary Care and Health SciencesDavid Weatherall Building, Keele University CampusKeeleStaffordshireUKST5 5BG
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Norman G, Westby MJ, Rithalia AD, Stubbs N, Soares MO, Dumville JC, Cochrane Wounds Group. Dressings and topical agents for treating venous leg ulcers. Cochrane Database Syst Rev 2018; 6:CD012583. [PMID: 29906322 PMCID: PMC6513558 DOI: 10.1002/14651858.cd012583.pub2] [Citation(s) in RCA: 38] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND Venous leg ulcers are open skin wounds on the lower leg which can be slow to heal, and are both painful and costly. The point prevalence of open venous leg ulcers in the UK is about 3 cases per 10,000 people, and many people experience recurrent episodes of prolonged ulceration. First-line treatment for venous leg ulcers is compression therapy, but a wide range of dressings and topical treatments are also used. This diversity of treatments makes evidence-based decision-making challenging, and a clear and current overview of all the evidence is required. This review is a network meta-analysis (NMA) which assesses the probability of complete ulcer healing associated with alternative dressings and topical agents. OBJECTIVES To assess the effects of (1) dressings and (2) topical agents for healing venous leg ulcers in any care setting and to rank treatments in order of effectiveness, with assessment of uncertainty and evidence quality. SEARCH METHODS In March 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also scanned reference lists of relevant included studies as well as reviews, meta-analyses, guidelines and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. We updated this search in March 2018; as a result several studies are awaiting classification. SELECTION CRITERIA We included published or unpublished randomised controlled trials (RCTs) that enrolled adults with venous leg ulcers and compared the effects of at least one of the following interventions with any other intervention in the treatment of venous leg ulcers: any dressing, or any topical agent applied directly to an open venous leg ulcer and left in situ. We excluded from this review dressings attached to external devices such as negative pressure wound therapies, skin grafts, growth factors and other biological agents, larval therapy and treatments such as laser, heat or ultrasound. Studies were required to report complete wound healing to be eligible. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection, 'Risk of bias' assessment and data extraction. We conducted this NMA using frequentist meta-regression methods for the efficacy outcome; the probability of complete healing. We assumed that treatment effects were similar within dressings classes (e.g. hydrocolloid, foam). We present estimates of effect with their 95% confidence intervals (CIs) for individual treatments focusing on comparisons with widely used dressing classes, and we report ranking probabilities for each intervention (probability of being the best, second best, etc treatment). We assessed the certainty (quality) of the body of evidence using GRADE for each network comparison and for the network as whole. MAIN RESULTS We included 78 RCTs (7014 participants) in this review. Of these, 59 studies (5156 participants, 25 different interventions) were included in the NMA; resulting in 40 direct contrasts which informed 300 mixed-treatment contrasts.The evidence for the network as a whole was of low certainty. This judgement was based on the sparsity of the network leading to imprecision and the general high risk of bias in the included studies. Sensitivity analyses also demonstrated instability in key aspects of the network and results are reported for the extended sensitivity analysis. Evidence for individual contrasts was mainly judged to be low or very low certainty.The uncertainty was perpetuated when the results were considered by ranking the treatments in terms of the probability that they were the most effective for ulcer healing, with many treatments having similar, low, probabilities of being the best treatment. The two most highly-ranked treatments both had more than 50% probability of being the best (sucralfate and silver dressings). However, the data for sucralfate was from one small study, which means that this finding should be interpreted with caution. When exploring the data for silver and sucralfate compared with widely-used dressing classes, there was some evidence that silver dressings may increase the probability of venous leg ulcer healing, compared with nonadherent dressings: RR 2.43, 95% CI 1.58 to 3.74 (moderate-certainty evidence in the context of a low-certainty network). For all other combinations of these five interventions it was unclear whether the intervention increased the probability of healing; in each case this was low- or very low-certainty evidence as a consequence of one or more of imprecision, risk of bias and inconsistency. AUTHORS' CONCLUSIONS More research is needed to determine whether particular dressings or topical agents improve the probability of healing of venous leg ulcers. However, the NMA is uninformative regarding which interventions might best be included in a large trial, largely because of the low certainty of the whole network and of individual comparisons.The results of this NMA focus exclusively on complete healing; whilst this is of key importance to people living with venous leg ulcers, clinicians may wish to take into account other patient-important outcomes and factors such as patient preference and cost.
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Affiliation(s)
- Gill Norman
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
| | - Maggie J Westby
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
| | - Amber D Rithalia
- Independent Researcher7 Victoria Terrace, KirkstallLeedsUKLS5 3HX
| | - Nikki Stubbs
- St Mary's HospitalLeeds Community Healthcare NHS Trust3 Greenhill RoadLeedsUKLS12 3QE
| | - Marta O Soares
- University of YorkCentre for Health EconomicsAlcuin 'A' BlockHeslingtonYorkUKYO10 5DD
| | - Jo C Dumville
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and HealthJean McFarlane BuildingOxford RoadManchesterUKM13 9PL
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Rai R, Shenoy MM, Viswanath V, Sarma N, Majid I, Dogra S. Contact sensitivity in patients with venous leg ulcer: A multi-centric Indian study. Int Wound J 2018; 15:618-622. [PMID: 29600560 DOI: 10.1111/iwj.12905] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2017] [Revised: 01/23/2018] [Accepted: 01/23/2018] [Indexed: 01/19/2023] Open
Abstract
Venous leg ulcers are the most common form of non-healing leg ulcers. They are subjected to treatments such as topical medications, dressings, and compression therapies. This can lead to exposure to a number of allergens with subsequent sensitisation and contact dermatitis of the regional skin. This may contribute to the poor ulcer healing. To detect the various contact sensitisers in patients with venous leg ulcers through patch testing, patients from 6 centres across India with venous leg ulcers of longer than 6 weeks duration were enrolled for the study. They were patch tested using a special parch test kit with 27 antigens. A total of 172 patients were included in the study; 82 (48.2%) tested positive for at least 1 antigen. Among them, polyvalent sensitisation was noted in 71% of patients. Wood tar mix (10.4%) and the framycetin (8.7%) were the most common allergens. There is a high frequency of allergic sensitisation to various ingredients of topical therapies used in the venous ulcer management, which may interfere with wound healing. Avoiding them can help obtain a better therapeutic outcome.
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Affiliation(s)
- Reena Rai
- Department of Dermatology, Venereology & Leprosy, PSG Institute of Medical Sciences & Research, Coimbatore, India
| | - Manjunath M Shenoy
- Department of Dermatology, Venereology & Leprosy, Yenepoya Medical College, Mangalore, India
| | - Vishalakshi Viswanath
- Department of Dermatology, Venereology & Leprosy, Rajiv Gandhi Medical College & CSMH, Thane, India
| | - Nilendu Sarma
- Department of Dermatology, Venereology & Leprosy, Dr B C Roy Institute of Pediatric Science, Kolkata, 700054, India
| | - Imran Majid
- Department of Dermatology, Venereology & Leprosy, Govt Medical College, Srinagar, India
| | - Sunil Dogra
- Department of Dermatology, Venereology & Leprology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India
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Gray TA, Rhodes S, Atkinson RA, Rothwell K, Wilson P, Dumville JC, Cullum NA. Opportunities for better value wound care: a multiservice, cross-sectional survey of complex wounds and their care in a UK community population. BMJ Open 2018; 8:e019440. [PMID: 29572395 PMCID: PMC5875675 DOI: 10.1136/bmjopen-2017-019440] [Citation(s) in RCA: 79] [Impact Index Per Article: 11.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
BACKGROUND Complex wounds impose a substantial health economic burden worldwide. As wound care is managed across multiple settings by a range of healthcare professionals with varying levels of expertise, the actual care delivered can vary considerably and result in the underuse of evidence-based interventions, the overuse of interventions supported by limited evidence and low value healthcare. OBJECTIVES To quantify the number, type and management of complex wounds being treated over a two-week period and to explore variations in care by comparing current practices in wound assessment, prevention and treatment. DESIGN A multiservice cross-sectional survey. SETTING This survey spanned eight community services within five Northern England NHS Trusts. RESULTS The point prevalence of complex wounds in this community-based population was 16.4 per 10 000 (95% CI 15.9 to 17.0). Based on data from 3179 patients, antimicrobial dressings were being used as the primary dressing for 36% of patients with complex wounds. Forty per cent of people with leg ulcers either had not received the recommended Doppler-aided Ankle Brachial Pressure Index assessment or it was unclear whether a recording had been taken. Thirty-one per cent of patients whose most severe wound was a venous leg ulcer were not receiving compression therapy, and there was limited use of two-layer compression hosiery. Of patients with a pressure ulcer, 39% were not using a pressure-relieving cushion or mattress. CONCLUSIONS Marked variations were found in care, underuse of evidence-based practices and overuse of practices that are not supported by robust research evidence. Significant opportunities for delivering better value wound care therefore exist. Efforts should now focus on developing strategies to identify, assess and disinvest from products and practices supported by little or no evidence and enhance the uptake of those that are.
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Affiliation(s)
- Trish A Gray
- Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
| | - Sarah Rhodes
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
- Centre for Biostatistics, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Ross A Atkinson
- Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
| | - Katy Rothwell
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
| | - Paul Wilson
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
- Alliance Manchester Business School, University of Manchester, Manchester, UK
| | - Jo C Dumville
- Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
| | - Nicky A Cullum
- Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
- NIHR CLAHRC Greater Manchester, Salford Royal NHS Foundation Trust, Salford, UK
- Research and Innovation Division, Manchester University NHS Foundation Trust, Manchester, UK
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Tong QJ, Hammer KD, Johnson EM, Zegarra M, Goto M, Lo TS. A systematic review and meta-analysis on the use of prophylactic topical antibiotics for the prevention of uncomplicated wound infections. Infect Drug Resist 2018; 11:417-425. [PMID: 29588605 PMCID: PMC5858851 DOI: 10.2147/idr.s151293] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
Background The prescription of topical antibiotics for the prevention of infections in uncomplicated wounds is common. However, the efficacy is not well reported. Therefore, the objective of the study was to conduct a systematic review and meta-analysis of the available evidence on prevention of uncomplicated wound infections by prophylactic topical antibiotics. Materials and methods The search included Pubmed, Google Scholar, SCOPUS, Embase, Cochrane, ClinicalTrials.gov, International Clinical Trials Registry Platform, National Technical Information Service, and the National Guidelines Clearinghouse. Results We identified eight randomized controlled trials and four quasi-randomized trials that met the criteria for the systematic review. Of these trials, 11 studies were pooled for meta-analysis to compare the effects of topical antibiotics versus placebo and 4 studies were pooled for comparison of effects of topical antibiotics versus topical antiseptics on uncomplicated wounds. Fewer wound infections occurred in the topical antibiotic arms compared to placebo (pooled risk ratio: 0.57 [95% CI: 0.37 to 0.86]; p=0.01 and pooled risk difference: −3.1% [95% CI: −5.8% to −0.34%]; p=0.03). Compared to antiseptics, topical antibiotics demonstrated statistically significant relative risk reduction (pooled risk ratio: 0.56 [95% CI: 0.23 to 0.91]; p=0.02), while there was no significant absolute risk reduction (pooled risk difference: −3.7% [95% CI: −7.9% to +0.6%]; p=0.09). Conclusion Topical antibiotics are effective in reducing wound infections after surgical procedures, but the absolute benefit is small. Given the global emergence of antimicrobial resistance, judicious use of antibiotics is encouraged and use of antiseptics should be considered as a reasonable alternative to topical antibiotics.
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Affiliation(s)
- Qiao-Jing Tong
- Department of Infection Control, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
| | - Kimberly Dp Hammer
- Research Service, Fargo VA Health Care System.,Department of Internal Medicine, University of North Dakota, School of Medicine and Health Sciences, Fargo, ND, USA
| | - Erika M Johnson
- Library Resources, University of North Dakota, School of Medicine and Health Sciences, Fargo, ND, USA
| | - Milagros Zegarra
- Research Service, Fargo VA Health Care System.,Department of Internal Medicine, University of North Dakota, School of Medicine and Health Sciences, Fargo, ND, USA
| | - Michihiko Goto
- Center for Comprehensive Access & Delivery Research & Evaluation (CADRE), Iowa City VA Health Care System, West Iowa City, IA, USA.,Department of Internal Medicine, University of Iowa, Carver College of Medicine, Iowa City, IA, USA
| | - Tze Shien Lo
- Department of Internal Medicine, University of North Dakota, School of Medicine and Health Sciences, Fargo, ND, USA.,Infectious Disease Service, Fargo VA Health Care System, Fargo, ND, USA
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Raftery J, Hanney S, Greenhalgh T, Glover M, Blatch-Jones A. Models and applications for measuring the impact of health research: update of a systematic review for the Health Technology Assessment programme. Health Technol Assess 2018; 20:1-254. [PMID: 27767013 DOI: 10.3310/hta20760] [Citation(s) in RCA: 46] [Impact Index Per Article: 6.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022] Open
Abstract
BACKGROUND This report reviews approaches and tools for measuring the impact of research programmes, building on, and extending, a 2007 review. OBJECTIVES (1) To identify the range of theoretical models and empirical approaches for measuring the impact of health research programmes; (2) to develop a taxonomy of models and approaches; (3) to summarise the evidence on the application and use of these models; and (4) to evaluate the different options for the Health Technology Assessment (HTA) programme. DATA SOURCES We searched databases including Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library from January 2005 to August 2014. REVIEW METHODS This narrative systematic literature review comprised an update, extension and analysis/discussion. We systematically searched eight databases, supplemented by personal knowledge, in August 2014 through to March 2015. RESULTS The literature on impact assessment has much expanded. The Payback Framework, with adaptations, remains the most widely used approach. It draws on different philosophical traditions, enhancing an underlying logic model with an interpretative case study element and attention to context. Besides the logic model, other ideal type approaches included constructionist, realist, critical and performative. Most models in practice drew pragmatically on elements of several ideal types. Monetisation of impact, an increasingly popular approach, shows a high return from research but relies heavily on assumptions about the extent to which health gains depend on research. Despite usually requiring systematic reviews before funding trials, the HTA programme does not routinely examine the impact of those trials on subsequent systematic reviews. The York/Patient-Centered Outcomes Research Institute and the Grading of Recommendations Assessment, Development and Evaluation toolkits provide ways of assessing such impact, but need to be evaluated. The literature, as reviewed here, provides very few instances of a randomised trial playing a major role in stopping the use of a new technology. The few trials funded by the HTA programme that may have played such a role were outliers. DISCUSSION The findings of this review support the continued use of the Payback Framework by the HTA programme. Changes in the structure of the NHS, the development of NHS England and changes in the National Institute for Health and Care Excellence's remit pose new challenges for identifying and meeting current and future research needs. Future assessments of the impact of the HTA programme will have to take account of wider changes, especially as the Research Excellence Framework (REF), which assesses the quality of universities' research, seems likely to continue to rely on case studies to measure impact. The HTA programme should consider how the format and selection of case studies might be improved to aid more systematic assessment. The selection of case studies, such as in the REF, but also more generally, tends to be biased towards high-impact rather than low-impact stories. Experience for other industries indicate that much can be learnt from the latter. The adoption of researchfish® (researchfish Ltd, Cambridge, UK) by most major UK research funders has implications for future assessments of impact. Although the routine capture of indexed research publications has merit, the degree to which researchfish will succeed in collecting other, non-indexed outputs and activities remains to be established. LIMITATIONS There were limitations in how far we could address challenges that faced us as we extended the focus beyond that of the 2007 review, and well beyond a narrow focus just on the HTA programme. CONCLUSIONS Research funders can benefit from continuing to monitor and evaluate the impacts of the studies they fund. They should also review the contribution of case studies and expand work on linking trials to meta-analyses and to guidelines. FUNDING The National Institute for Health Research HTA programme.
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Affiliation(s)
- James Raftery
- Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK
| | - Steve Hanney
- Health Economics Research Group (HERG), Institute of Environment, Health and Societies, Brunel University London, London, UK
| | - Trish Greenhalgh
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Matthew Glover
- Health Economics Research Group (HERG), Institute of Environment, Health and Societies, Brunel University London, London, UK
| | - Amanda Blatch-Jones
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
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Vestjens JJHHM, Rondas AALM, White RRJ, Holloway SSL. The inter-rater reliability between nurse-assessors clinically assessing infection of chronic wounds using the WUWHS criteria. Int Wound J 2018; 15:8-15. [PMID: 29076279 PMCID: PMC7950052 DOI: 10.1111/iwj.12785] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/12/2017] [Revised: 05/27/2017] [Accepted: 05/31/2017] [Indexed: 11/30/2022] Open
Abstract
The aim of this study was to determine the inter-rater reliability between one expert-nurse and four clinical-nurses who were asked to clinically assess infection of chronic wounds by using the World Union of Wound Healing Societies (WUWHS) criteria. A quasi-experimental design was used to collect the data. In comparison to phase 1 in which 'open questions' were asked, in phase 2 a pre-printed form (checklist) was introduced. In both phases, 55 chronic wounds were clinically assessed. For each WUWHS criterion the inter-rater reliability of signs and symptoms was expressed by Cohens Kappa (κ). A substantial agreement (κ ≥ 0·6) was considered as adequate. In both phases pocketing (p < 0·02), and erythema (p < 0·004) scored statistically significant results. Phase 2 showed higher inter-rater agreements compared with phase 1 (three substantial agreements (easily bleeding/friable granulation tissue, delayed healing, increasing exudate), an almost perfect- and a perfect agreement for malodour and pain, respectively. According to the results it can be concluded that the clinical assessment of infection of chronic wounds may be better supported by a pre-printed form than making use of an 'open questions' form. To provide this with a higher level of evidence, there is need for more well conducted studies.
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Affiliation(s)
| | - Armand ALM Rondas
- De Zorggroep, Kenniscentrum WondbehandelingVenraythe Netherlands
- Department of Health Services Research, Maastricht University, CAPHRIMaastrichtthe Netherlands
| | - Richard RJ White
- Department of Tissue Viability University of WorcesterWorcesterUK
| | - Samantha SL Holloway
- Department of Cardiff University School of MedicineCentre for Medical Education, College of Biomedical and Life SciencesCardiffUK
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Jindal R, Dekiwadia DB, Krishna PR, Khanna AK, Patel MD, Padaria S, Varghese R. Evidence-Based Clinical Practice Points for the Management of Venous Ulcers. Indian J Surg 2018; 80:171-182. [PMID: 29915484 DOI: 10.1007/s12262-018-1726-3] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2017] [Accepted: 01/15/2018] [Indexed: 10/18/2022] Open
Abstract
Venous ulcer is an extremely common aetiology of lower extremity ulceration, which affects approximately 1% population in most of the countries, and the incidence rate increases with age and female gender. Proper assessment and diagnosis of both the patient and ulcer are inevitable in order to differentiate venous ulcers from other lower extremity ulceration and to frame an adequate and individualised management plan. Venous ulcers generally persist for weeks to many years and are typically recurrent in nature. This consensus aims to present an evidence-based management approach for the patients with venous ulcers. Various management options for venous ulcers include compression therapy, minimally invasive procedures like sclerotherapy and ablation techniques, surgical procedures, debridement and medical management with micronised purified flavonoid fraction (MPFF). Compression therapy is the mainstay treatment for venous ulcer. However, in failure cases, surgery can be preferred. Medical management with MPFF as an adjuvant therapy to standard treatment has been reported to be effective and safe in patients with venous ulcer. In addition to standard therapy, diet and lifestyle modification including progressive resistance exercise, patient education, leg elevation, weight reduction, maintaining a healthy cardiac status and strong psychosocial support reduces the risk of recurrence and improves the quality of life in patients with venous ulcer.
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Affiliation(s)
| | | | | | - Ajay K Khanna
- 4Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
| | | | - Shoaib Padaria
- Jaslok Hospital, Breach Candy Hospital, Sir H.N. Hospital, Saifee Hospital, Mumbai, India
| | - Roy Varghese
- 7Daya Hospital, Jubilee Mission Medical College, Trichur, Kerala India
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Guest JF, Fuller GW, Vowden P. Venous leg ulcer management in clinical practice in the UK: costs and outcomes. Int Wound J 2017; 15:29-37. [PMID: 29243398 DOI: 10.1111/iwj.12814] [Citation(s) in RCA: 136] [Impact Index Per Article: 17.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2017] [Revised: 07/27/2017] [Accepted: 08/04/2017] [Indexed: 11/27/2022] Open
Abstract
The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.
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Affiliation(s)
- Julian F Guest
- Catalyst Health Economics Consultants, Rickmansworth, UK.,Faculty of Life Sciences and Medicine, King's College, London, UK
| | | | - Peter Vowden
- Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK and University of Bradford, Bradford, UK
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Review of local wound management for scleroderma-associated digital ulcers. JOURNAL OF SCLERODERMA AND RELATED DISORDERS 2017; 3:66-70. [PMID: 32099902 DOI: 10.5301/jsrd.5000268] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
Digital ulcers (DU) are a common clinical problem in systemic sclerosis (SSc); however, there is no standardization of local wound care protocols for management of these lesions. There is a well-recognized need to develop and standardize non-pharmacological management of DU in patients with SSc, and to adopt these protocols in future clinical trials that focus on DU healing. The purpose of this review is to outline the types of DU that occur in SSc, and provide an update on the principles of wound management for these lesions based on the current literature and expert opinion.
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Current and Emerging Topical Antibacterials and Antiseptics: Agents, Action, and Resistance Patterns. Clin Microbiol Rev 2017; 30:827-860. [PMID: 28592405 DOI: 10.1128/cmr.00112-16] [Citation(s) in RCA: 221] [Impact Index Per Article: 27.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022] Open
Abstract
Bacterial skin infections represent some of the most common infectious diseases globally. Prevention and treatment of skin infections can involve application of a topical antimicrobial, which may be an antibiotic (such as mupirocin or fusidic acid) or an antiseptic (such as chlorhexidine or alcohol). However, there is limited evidence to support the widespread prophylactic or therapeutic use of topical agents. Challenges involved in the use of topical antimicrobials include increasing rates of bacterial resistance, local hypersensitivity reactions (particularly to older agents, such as bacitracin), and concerns about the indiscriminate use of antiseptics potentially coselecting for antibiotic resistance. We review the evidence for the major clinical uses of topical antibiotics and antiseptics. In addition, we review the mechanisms of action of common topical agents and define the clinical and molecular epidemiology of antimicrobial resistance in these agents. Moreover, we review the potential use of newer and emerging agents, such as retapamulin and ebselen, and discuss the role of antiseptic agents in preventing bacterial skin infections. A comprehensive understanding of the clinical efficacy and drivers of resistance to topical agents will inform the optimal use of these agents to preserve their activity in the future.
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Westby MJ, Dumville JC, Stubbs N, Norman G, Wong JKF, Cullum N, Riley R. Protease activity as a prognostic factor for wound healing in venous leg ulcers. Hippokratia 2017. [DOI: 10.1002/14651858.cd012841] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Affiliation(s)
- Maggie J Westby
- University of Manchester, Manchester Academic Health Science Centre; Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health; Jean McFarlane Building Oxford Road Manchester UK M13 9PL
| | - Jo C Dumville
- University of Manchester, Manchester Academic Health Science Centre; Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health; Jean McFarlane Building Oxford Road Manchester UK M13 9PL
| | - Nikki Stubbs
- Leeds Community Healthcare NHS Trust, St Mary's Hospital; Wound Prevention and Management Service; 3 Greenhill Road Leeds UK LS12 3QE
| | - Gill Norman
- University of Manchester, Manchester Academic Health Science Centre; Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health; Jean McFarlane Building Oxford Road Manchester UK M13 9PL
| | - Jason KF Wong
- University Hospital South Manchester; Plastic and Reconstructive Surgery; Southmoor Road, Wythenshawe Manchester UK M23 9LT
| | - Nicky Cullum
- University of Manchester, Manchester Academic Health Science Centre; Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health; Jean McFarlane Building Oxford Road Manchester UK M13 9PL
| | - Richard Riley
- Keele University; Research Institute for Primary Care and Health Sciences; David Weatherall Building, Keele University Campus Keele Staffordshire UK ST5 5BG
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Dumville JC, Lipsky BA, Hoey C, Cruciani M, Fiscon M, Xia J, Cochrane Wounds Group. Topical antimicrobial agents for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev 2017; 6:CD011038. [PMID: 28613416 PMCID: PMC6481886 DOI: 10.1002/14651858.cd011038.pub2] [Citation(s) in RCA: 54] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
BACKGROUND People with diabetes are at high risk for developing foot ulcers, which often become infected. These wounds, especially when infected, cause substantial morbidity. Wound treatments should aim to alleviate symptoms, promote healing, and avoid adverse outcomes, especially lower extremity amputation. Topical antimicrobial therapy has been used on diabetic foot ulcers, either as a treatment for clinically infected wounds, or to prevent infection in clinically uninfected wounds. OBJECTIVES To evaluate the effects of treatment with topical antimicrobial agents on: the resolution of signs and symptoms of infection; the healing of infected diabetic foot ulcers; and preventing infection and improving healing in clinically uninfected diabetic foot ulcers. SEARCH METHODS We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in August 2016. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists to identify additional studies. We used no restrictions with respect to language, date of publication, or study setting. SELECTION CRITERIA We included randomised controlled trials conducted in any setting (inpatient or outpatient) that evaluated topical treatment with any type of solid or liquid (e.g., cream, gel, ointment) antimicrobial agent, including antiseptics, antibiotics, and antimicrobial dressings, in people with diabetes mellitus who were diagnosed with an ulcer or open wound of the foot, whether clinically infected or uninfected. DATA COLLECTION AND ANALYSIS Two review authors independently performed study selection, 'Risk of bias' assessment, and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary. MAIN RESULTS We found 22 trials that met our inclusion criteria with a total of over 2310 participants (one study did not report number of participants). The included studies mostly had small numbers of participants (from 4 to 317) and relatively short follow-up periods (4 to 24 weeks). At baseline, six trials included only people with ulcers that were clinically infected; one trial included people with both infected and uninfected ulcers; two trials included people with non-infected ulcers; and the remaining 13 studies did not report infection status.Included studies employed various topical antimicrobial treatments, including antimicrobial dressings (e.g. silver, iodides), super-oxidised aqueous solutions, zinc hyaluronate, silver sulphadiazine, tretinoin, pexiganan cream, and chloramine. We performed the following five comparisons based on the included studies: Antimicrobial dressings compared with non-antimicrobial dressings: Pooled data from five trials with a total of 945 participants suggest (based on the average treatment effect from a random-effects model) that more wounds may heal when treated with an antimicrobial dressing than with a non-antimicrobial dressing: risk ratio (RR) 1.28, 95% confidence interval (CI) 1.12 to 1.45. These results correspond to an additional 119 healing events in the antimicrobial-dressing arm per 1000 participants (95% CI 51 to 191 more). We consider this low-certainty evidence (downgraded twice due to risk of bias). The evidence on adverse events or other outcomes was uncertain (very low-certainty evidence, frequently downgraded due to risk of bias and imprecision). Antimicrobial topical treatments (non dressings) compared with non-antimicrobial topical treatments (non dressings): There were four trials with a total of 132 participants in this comparison that contributed variously to the estimates of outcome data. Evidence was generally of low or very low certainty, and the 95% CIs spanned benefit and harm: proportion of wounds healed RR 2.82 (95% CI 0.56 to 14.23; 112 participants; 3 trials; very low-certainty evidence); achieving resolution of infection RR 1.16 (95% CI 0.54 to 2.51; 40 participants; 1 trial; low-certainty evidence); undergoing surgical resection RR 1.67 (95% CI 0.47 to 5.90; 40 participants; 1 trial; low-certainty evidence); and sustaining an adverse event (no events in either arm; 81 participants; 2 trials; very low-certainty evidence). Comparison of different topical antimicrobial treatments: We included eight studies with a total of 250 participants, but all of the comparisons were different and no data could be appropriately pooled. Reported outcome data were limited and we are uncertain about the relative effects of antimicrobial topical agents for each of our review outcomes for this comparison, that is wound healing, resolution of infection, surgical resection, and adverse events (all very low-certainty evidence). Topical antimicrobials compared with systemic antibiotics : We included four studies with a total of 937 participants. These studies reported no wound-healing data, and the evidence was uncertain for the relative effects on resolution of infection in infected ulcers and surgical resection (very low certainty). On average, there is probably little difference in the risk of adverse events between the compared topical antimicrobial and systemic antibiotics treatments: RR 0.91 (95% CI 0.78 to 1.06; moderate-certainty evidence - downgraded once for inconsistency). Topical antimicrobial agents compared with growth factor: We included one study with 40 participants. The only review-relevant outcome reported was number of ulcers healed, and these data were uncertain (very low-certainty evidence). AUTHORS' CONCLUSIONS The randomised controlled trial data on the effectiveness and safety of topical antimicrobial treatments for diabetic foot ulcers is limited by the availability of relatively few, mostly small, and often poorly designed trials. Based on our systematic review and analysis of the literature, we suggest that: 1) use of an antimicrobial dressing instead of a non-antimicrobial dressing may increase the number of diabetic foot ulcers healed over a medium-term follow-up period (low-certainty evidence); and 2) there is probably little difference in the risk of adverse events related to treatment between systemic antibiotics and topical antimicrobial treatments based on the available studies (moderate-certainty evidence). For each of the other outcomes we examined there were either no reported data or the available data left us uncertain as to whether or not there were any differences between the compared treatments. Given the high, and increasing, frequency of diabetic foot wounds, we encourage investigators to undertake properly designed randomised controlled trials in this area to evaluate the effects of topical antimicrobial treatments for both the prevention and the treatment of infection in these wounds and ultimately the effects on wound healing.
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Affiliation(s)
- Jo C Dumville
- University of Manchester, Manchester Academic Health Science CentreDivision of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & HealthManchesterUKM13 9PL
| | - Benjamin A Lipsky
- Green Templeton College, University of OxfordDivision of Medical Sciences79 Stone MeadowOxfordUKOX2 6TD
| | - Christopher Hoey
- VA Puget Sound Health Care System Medical CenterPharmacy and Nutritional CareS‐Pharm‐1191660 S. Columbian WaySeattleWAUSA98108‐1597
| | - Mario Cruciani
- Azienda ULSS9 ScaligeraAntibiotic Stewardship ProgrammeVeronaItaly37135
| | - Marta Fiscon
- University of VeronaCentro Malattie DiffusiveULSS20VeronaItaly
| | - Jun Xia
- The Ingenuity Centre, The University of NottinghamSystematic Review Solutions LtdTriumph RoadNottinghamUKNG7 2TU
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