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Lake SP, Deeken CR, Agarwal AK. Reinforced tissue matrix to strengthen the abdominal wall following reversal of temporary ostomies or to treat incisional hernias. World J Gastrointest Surg 2024; 16:823-832. [PMID: 38577081 PMCID: PMC10989334 DOI: 10.4240/wjgs.v16.i3.823] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/27/2023] [Revised: 01/03/2024] [Accepted: 02/25/2024] [Indexed: 03/22/2024] Open
Abstract
BACKGROUND Abdominal wall deficiencies or weakness are a common complication of temporary ostomies, and incisional hernias frequently develop after colostomy or ileostomy takedown. The use of synthetic meshes to reinforce the abdominal wall has reduced hernia occurrence. Biologic meshes have also been used to enhance healing, particularly in contaminated conditions. Reinforced tissue matrices (RTMs), which include a biologic scaffold of native extracellular matrix and a synthetic component for added strength/durability, are designed to take advantage of aspects of both synthetic and biologic materials. To date, RTMs have not been reported to reinforce the abdominal wall following stoma reversal. AIM To evaluate the effectiveness of using an RTM to reinforce the abdominal wall at stoma takedown sites. METHODS Twenty-eight patients were selected with a parastomal and/or incisional hernia who had received a temporary ileostomy or colostomy for fecal diversion after rectal cancer treatment or trauma. Following hernia repair and proximal stoma closure, RTM (OviTex® 1S permanent or OviTex® LPR) was placed to reinforce the abdominal wall using a laparoscopic, robotic, or open surgical approach. Post-operative follow-up was performed at 1 month and 1 year. Hernia recurrence was determined by physical examination and, when necessary, via computed tomography scan. Secondary endpoints included length of hospital stay, time to return to work, and hospital readmissions. Evaluated complications of the wound/repair site included presence of surgical site infection, seroma, hematoma, wound dehiscence, or fistula formation. RESULTS The observational study cohort included 16 male and 12 female patients with average age of 58.5 years ± 16.3 years and average body mass index of 26.2 kg/m2 ± 4.1 kg/m2. Patients presented with a parastomal hernia (75.0%), incisional hernia (14.3%), or combined parastomal/incisional hernia (10.7%). Using a laparoscopic (53.6%), robotic (35.7%), or open (10.7%) technique, RTMs (OviTex® LPR: 82.1%, OviTex® 1S: 17.9%) were placed using sublay (82.1%) or intraperitoneal onlay (IPOM; 17.9%) mesh positioning. At 1-month and 1-year follow-ups, there were no hernia recurrences (0%). Average hospital stays were 2.1 d ± 1.2 d and return to work occurred at 8.3 post-operative days ± 3.0 post-operative days. Three patients (10.7%) were readmitted before the 1-month follow up due to mesh infection and/or gastrointestinal issues. Fistula and mesh infection were observed in two patients each (7.1%), leading to partial mesh removal in one patient (3.6%). There were no complications between 1 month and 1 year (0%). CONCLUSION RTMs were used successfully to treat parastomal and incisional hernias at ileostomy reversal, with no hernia recurrences and favorable outcomes after 1-month and 1-year.
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Affiliation(s)
- Spencer P Lake
- Mechanical Engineering & Materials Science, Washington University in St. Louis, St. Louis, MO 63130, United States
| | | | - Amit K Agarwal
- Department of Surgery, McGovern Medical School at UTHealth, Houston, TX 77026, United States
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Overbeck N, Beierschmitt A, May BCH, Qi S, Koch J. In-Vivo Evaluation of a Reinforced Ovine Biologic for Plastic and Reconstructive Procedures in a Non-human Primate Model of Soft Tissue Repair. EPLASTY 2022; 22:e43. [PMID: 36160663 PMCID: PMC9490877] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Indexed: 06/16/2023]
Abstract
BACKGROUND Biologic matrices are used in plastic and reconstructive surgical procedures to aid in the kinetics of soft tissue repair and promote functional tissue formation. The human acellular dermal matrix AlloDerm is widely used; however, it is offered at a relatively high cost, and its dermal composition may not provide an ideal remodeling scaffold. OviTex Plastic and Reconstructive Surgery (PRS) Resorbable and Permanent are reinforced biologic matrices engineered with layers of ovine forestomach matrix embroidered with small amounts of polymer to optimize biophysical performance. This study compared the healing outcomes of these matrices in a non-human primate model of soft tissue repair. METHODS Animals were implanted with test articles in surgically created full-thickness midline abdominal wall defects and evaluated macroscopically and histologically at 2, 4, 12, and 24 weeks. RESULTS Both OviTex PRS Permanent and Resorbable matrices exhibited earlier host cell infiltration, neovascularization, and collagen deposition and also fully remodeled into the host tissue by 12 weeks post implantation. AlloDerm had less host cell infiltration and neovascularization at early time points and never fully integrated into the surrounding host tissue. There was no statistical difference in overall inflammation between AlloDerm and either OviTex PRS product at any time point, despite small amounts of polymer reinforcement in OviTex products. CONCLUSIONS In a primate soft tissue repair model, OviTex PRS Permanent and Resorbable matrices performed comparably with the leading human acellular dermal matrix. OviTex PRS Permanent and Resorbable are less expensive than alternatives like AlloDerm and may promote faster host cell proliferation and functional remodeling in some soft tissue repair applications.
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Affiliation(s)
| | - Amy Beierschmitt
- Behavioural Science Foundation, Basseterre, Saint Kitts and Nevis
| | | | - Shijie Qi
- University of Montreal, Montreal, QC, Canada
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Miller DL, Durden FL. Chest Wall Reconstruction Utilizing Ovine-Derived Reinforced Tissue Matrix. Ann Thorac Surg 2022; 115:1266-1272. [PMID: 35085519 DOI: 10.1016/j.athoracsur.2021.12.062] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2021] [Revised: 11/17/2021] [Accepted: 12/22/2021] [Indexed: 11/24/2022]
Abstract
BACKGROUND Chest wall reconstruction (CWR) can be a challenge. The perfect material does not exist to restore CW stability. Synthetic materials have been the mainstay for reconstruction. Biological material use has increased. Recently, we initiated the use of a biosynthetic material (BSM) for CWR that is composed of ovine-derived extracellular tissue matrix and monofilament polypropylene suture. METHODS We respectively reviewed all patients who underwent CWR with a BSM from January 2020 - June 2021. RESULTS Twenty-five patients underwent CWR. Median age was 35 years (18 - 68); 64% were men. Indication for CWR was tumor resection in 10, chest wall defect after pectus repair in 7, radiation necrosis in 5, chest wall infection in 2 and lung herniation in 1. Infection was present in 28%. Median CW defect was 7 x 10 cm (3.5 - 22.5 cm). Bioabsorbable bars were used in combination with the BSM patch in 15 patients (60%) and BSM alone in 10; 5 patients underwent myocutaneous advancement flaps. There were no operative deaths. Postoperative complications occurred in 6 patients (24%). Median hospital stay was 5 days (3 - 14). Late complications occurred in 4 patients (16%). No patient developed paradoxical motion, chest wall instability, or required BSM removal at a median follow-up of 12 months (1 - 18). CONCLUSIONS This novel BSM combines the benefits of biologic material and polymer reinforcement to provide a more natural CWR compared to mesh products made of synthetic material alone. Early results are promising in this first series in the literature.
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Affiliation(s)
- Daniel L Miller
- Department of Surgery, Medical College of Georgia, Augusta University, Augusta, GA.
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Smith MJ, Dempsey SG, Veale RWF, Duston-Fursman CG, Rayner CAF, Javanapong C, Gerneke D, Dowling SG, Bosque BA, Karnik T, Jerram MJ, Nagarajan A, Rajam R, Jowsey A, Cutajar S, Mason I, Stanley RG, Campbell A, Malmstrom J, Miller CH, May BCH. Further structural characterization of ovine forestomach matrix and multi-layered extracellular matrix composites for soft tissue repair. J Biomater Appl 2022; 36:996-1010. [PMID: 34747247 PMCID: PMC8721687 DOI: 10.1177/08853282211045770] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
Decellularized extracellular matrix (dECM)-based biomaterials are of great clinical utility in soft tissue repair applications due to their regenerative properties. Multi-layered dECM devices have been developed for clinical indications where additional thickness and biomechanical performance are required. However, traditional approaches to the fabrication of multi-layered dECM devices introduce additional laminating materials or chemical modifications of the dECM that may impair the biological functionality of the material. Using an established dECM biomaterial, ovine forestomach matrix, a novel method for the fabrication of multi-layered dECM constructs has been developed, where layers are bonded via a physical interlocking process without the need for additional bonding materials or detrimental chemical modification of the dECM. The versatility of the interlocking process has been demonstrated by incorporating a layer of hyaluronic acid to create a composite material with additional biological functionality. Interlocked composite devices including hyaluronic acid showed improved in vitro bioactivity and moisture retention properties.
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Affiliation(s)
- Matthew J Smith
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Sandi G Dempsey
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Robert WF Veale
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | | | - Chloe A F Rayner
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Chettha Javanapong
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Dane Gerneke
- Auckland Bioengineering Institute, The University of Auckland, Auckland, New Zealand
| | - Shane G Dowling
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Brandon A Bosque
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Tanvi Karnik
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Michael J Jerram
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Arun Nagarajan
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Ravinder Rajam
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Alister Jowsey
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Samuel Cutajar
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Isaac Mason
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Roderick G Stanley
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Andrew Campbell
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Jenny Malmstrom
- Department of Chemical and Materials Engineering, The University of Auckland, Auckland, New Zealand
| | - Chris H Miller
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
| | - Barnaby C H May
- Department of Research and Clinical Development, Aroa Biosurgery Limited, Auckland, New Zealand
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Chaffin AE, Dowling SG, Kosyk MS, Bosque BA. Surgical reconstruction of pilonidal sinus disease with concomitant extracellular matrix graft placement: a case series. J Wound Care 2021; 30:S28-S34. [PMID: 34256587 DOI: 10.12968/jowc.2021.30.sup7.s28] [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: 11/11/2022]
Abstract
BACKGROUND Pilonidal sinus disease (PSD) is a chronic inflammatory disease affecting the soft tissue of the sacrococcygeal region and remains a challenging disease for clinicians to treat. The optimal treatment for PSD remains controversial and recent reports describe several different surgical approaches offering different benefits. Approximately 40% of initial incision and drainage cases require subsequent surgery. Due to high recurrence rates and postoperative complications, a more complex revision surgery involving a flap reconstruction may be required. We hypothesised that the combination of an extracellular matrix (ECM) graft with tissue flap reconstruction may decrease the postoperative complications and recurrence rates for PSD. METHOD We report a retrospective case series using a surgical flap reconstruction with concomitant implantation of an ovine forestomach ECM graft under a fasciocutaneous flap with an off-midline closure for recurrent PSD, where previously surgical intervention had failed due to wound dehiscence and/or recurrent disease. RESULTS The case series included six patients. After three weeks, all patients except one were fully healed, and the sixth was fully healed by week 4; all wounds remained fully healed at 12 weeks. All patients achieved good cosmesis and were able to return to normal function without any residual symptoms. CONCLUSION This pilot case series explored augmenting a flap reconstruction for complex PSD with advanced ECM graft materials, demonstrating that it may improve outcomes and minimise typical complications seen in flap closure, such as inflammation, infection, haematoma/seroma and hypoperfusion. Although the study had a limited number of participants, long-term outcomes were promising and suggest that further studies are warranted.
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Affiliation(s)
- Abigail E Chaffin
- Division of Plastic and Reconstructive Surgery, Tulane University School of Medicine, New Orleans, US
| | | | - Mychajlo S Kosyk
- Division of Plastic and Reconstructive Surgery, Tulane University School of Medicine, New Orleans, US
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Bohn GA, Chaffin AE. Extracellular matrix graft for reconstruction over exposed structures: a pilot case series. J Wound Care 2021; 29:742-749. [PMID: 33320746 DOI: 10.12968/jowc.2020.29.12.742] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
Abstract
OBJECTIVE Soft tissue defects, especially those involving exposed vital structures, present a reconstructive challenge because poor vascularity of such defects typically makes immediate skin grafting unviable. Where flap procedures are inappropriate or not possible, dermal matrices represent an alternative reconstructive option for defects with denuded vital structures. With dermal matrices becoming increasingly available and technologically advanced, we evaluated an ovine-derived extracellular matrix graft in the reconstruction of complex soft tissue defects involving exposed vital structures. METHOD Six cases of soft tissue defects exhibiting denuded vital structures underwent reconstruction using an ovine forestomach matrix graft as a dermal matrix. Grafts were fixed directly into defects for immediate coverage and subsequently temporised defects via granulation tissue formation for later skin graft or secondary closure. Defect granulation and epithelialisation were monitored until closure and the final aesthetic and functional outcomes were evaluated. RESULTS Complete healing was achieved in all cases, with defect granulation becoming observable within one to two weeks and complete granulation occurring within one to six weeks. Granulation tissue resulting from the graft was suitable for skin grafting, with 100% take of skin grafts after one week and complete re-epithelialisation in two to three weeks in the four cases that received a skin graft. Good cosmetic, functional and patient satisfaction outcomes were achieved in all cases. CONCLUSION The present series demonstrates our initial use of an extracellular matrix-based dermal matrix in reconstructing defects with exposed vital structures. While such dermal matrices do not supersede or replace flap procedures, they represent an alternative option on the reconstructive ladder in cases where flap procedures are not appropriate or possible.
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Affiliation(s)
- Gregory A Bohn
- Department of Surgery, Central Michigan School of Medicine, St. Joseph Hospital, 200 Hemlock Rd, Tawas City, Michigan 48763, US
| | - Abigail E Chaffin
- Department of Surgery, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, Louisiana 70112, US
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Sawyer M, Ferzoco S, DeNoto G. A Polymer-Biologic Hybrid Hernia Construct: Review of Data and Early Experiences. Polymers (Basel) 2021; 13:polym13121928. [PMID: 34200591 PMCID: PMC8228560 DOI: 10.3390/polym13121928] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/01/2021] [Revised: 06/04/2021] [Accepted: 06/07/2021] [Indexed: 12/17/2022] Open
Abstract
Surgical mesh reinforcement of the human abdominal wall has been found to reduce the chance of recurrence in hernia repairs. While traditionally polymer meshes have been used in hernia repair, alternative mesh options have been engineered to prevent the inflammatory foreign body response invoked by polymers. A reinforced tissue matrix (RTM) mesh has been developed by embedding a polymer within a decellularized extracellular matrix. This combination has been attributed to the recruitment of host cells, a pro-healing response, and attenuation of the foreign body response. This has been observed to lead to the regeneration of functional tissue within the repair site that is reinforced by the polymer to offload abdominal pressures over time. This manuscript presents the review of OviTex, an RTM, in several types of hernia repair. The authors have found that the use of RTM in hernia repair is effective in preventing foreign body response, promoting wound healing, and providing reinforcement to lower the risk of hernia recurrence.
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Affiliation(s)
- Michael Sawyer
- Department of Surgery, Oklahoma State University, Comanche County Memorial Hospital, Lawton, OK 73505, USA
- Correspondence:
| | - Stephen Ferzoco
- Department of Surgery, Atrius Health, Dedham, MA 02026, USA;
| | - George DeNoto
- General Surgery Department, St. Francis Hospital, Roslyn, NY 11576, USA;
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Prospective Multicenter Evaluation of an Advanced Extracellular Matrix for Wound Management. Adv Skin Wound Care 2021; 33:437-444. [PMID: 32472774 DOI: 10.1097/01.asw.0000667052.74087.d6] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
OBJECTIVE To evaluate an advanced extracellular matrix made of ovine forestomach matrix (OFM) for healing a variety of wound types. METHODS Participants were enrolled from inpatient, outpatient, and home healthcare settings. The OFM was used to treat all wounds and applied to the wound bed every 3 to 7 days until closure. RESULTS Researchers enrolled 29 participants with 33 wounds. Average time to wound closure was 8.2 weeks, the percentage of wounds that reduced in size by 50% or more at 4 weeks was 64%, the average wound area reduction at 4 weeks was 66%, and 73% of wounds had closed at 12 weeks. No adverse effects were observed. CONCLUSIONS This represents the first Canadian evaluation of OFM for the treatment of wounds, and the positive healing outcomes observed could support more widespread adoption of this matrix.
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Liu W, Xie Y, Zheng Y, He W, Qiao K, Meng H. Regulatory science for hernia mesh: Current status and future perspectives. Bioact Mater 2021; 6:420-432. [PMID: 32995670 PMCID: PMC7490592 DOI: 10.1016/j.bioactmat.2020.08.021] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2020] [Revised: 08/16/2020] [Accepted: 08/23/2020] [Indexed: 11/25/2022] Open
Abstract
Regulatory science for medical devices aims to develop new tools, standards and approaches to assess the safety, effectiveness, quality and performance of medical devices. In the field of biomaterials, hernia mesh is a class of implants that have been successfully translated to clinical applications. With a focus on hernia mesh and its regulatory science system, this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American markets. The current development of regulatory science for hernia mesh, including its regulations, standards, guidance documents and classification, and the scientific evaluation of its safety and effectiveness was first reported. Then the research prospect of regulatory science for hernia mesh was discussed. New methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh, such as computational modeling, big data platform and evidence-based research, were assessed. By taking the regulatory science of hernia mesh as a case study, this review provided a research basis for developing a regulatory science system of implantable medical devices, furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory decision-making. This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants. It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.
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Affiliation(s)
- Wenbo Liu
- School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China
- Center for Medical Device Evaluation, National Medical Products Administration, Intellectual Property Publishing House Mansion, Qixiang Road, Haidian District, Beijing, China
| | - Yajie Xie
- School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China
| | - Yudong Zheng
- School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China
| | - Wei He
- School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China
| | - Kun Qiao
- School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China
| | - Haoye Meng
- School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China
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Desvigne MN, Bauer K, Holifield K, Day K, Gilmore D, Wardman AL. Case Report: Surgical Closure of Chronic Soft Tissue Defects Using Extracellular Matrix Graft Augmented Tissue Flaps. Front Surg 2021; 7:559450. [PMID: 33575271 PMCID: PMC7871006 DOI: 10.3389/fsurg.2020.559450] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/06/2020] [Accepted: 12/15/2020] [Indexed: 12/18/2022] Open
Abstract
Chronic soft tissue defects are notoriously difficult to heal. Surgical reconstruction of chronic defects using tissue flaps is a routine approach for closure of challenging chronic defects. Due to the poor tissue quality of chronic defects and associated inflammation, infection and impaired blood supply the success of flap closure is marred by reported complication rates of 25-58%. Extracellular matrix (ECM)-based graft materials are commonly used for resolving chronic wounds and in plastic and reconstructive procedures to create a scaffold for tissue regeneration. We hypothesized combination use of ECM grafts with tissue flaps in a single-stage surgical procedure would reduce complications and improve outcomes in the closure of chronic soft tissue defects. We report a case series (n = 9) of chronic soft tissue defect reconstruction using this modified procedure of ECM graft augmented flap closure. Defects included pressure injuries and surgical dehiscence and ranged in wound age from 5 months to 7 years. Successful uncomplicated healing was achieved in six defects. Post-operative complications (dehiscence) occurred in two defects, however, these healed via secondary intention without additional surgical intervention. All healed defects exhibited acceptable cosmesis and "normal" function, with 100% patient satisfaction. Augmentation of tissue flaps with ECM graft materials in this modified single-stage procedure may improve outcomes and minimize typical complications encountered in flap closure of chronic defects attributed to inflammation, infection, hypoperfusion, and dead space.
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Affiliation(s)
- Micheal N Desvigne
- Desvigne Plastic Surgery, Scottsdale, AZ, United States.,Abrazo Arrowhead Hospital, Glendale, AZ, United States
| | - Krista Bauer
- Abrazo Arrowhead Hospital, Glendale, AZ, United States
| | | | - Kari Day
- Abrazo Arrowhead Hospital, Glendale, AZ, United States
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Chaffin AE, Buckley MC. Extracellular matrix graft for the surgical management of Hurley stage III hidradenitis suppurativa: a pilot case series. J Wound Care 2020; 29:624-630. [DOI: 10.12968/jowc.2020.29.11.624] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
Objective: Surgical management of Hurley stage III hidradenitis suppurativa (HS) typically involves the excision of diseased tissue and subsequent reconstruction, potentially leading to complications or recurrence of the disease. This pilot case series sought to evaluate a decellularised ovine forestomach matrix (OFM) extracellular matrix (ECM) graft for soft tissue regeneration as part of surgical reconstruction of stage III HS of the axilla. Method: The prospective pilot case series involved six participants and a total of eight defects. The ECM graft was used either as a dermal substitute for a staged reconstruction (n=3 defects) or as an implant under a fasciocutaneous flap (n=5 defects) following wide excision of the diseased tissue. Results: In all cases complete healing was achieved, with no major surgical complications. When used as a dermal substitute the OFM graft was completely granulated within 2–4 weeks, with defects closing by secondary intention or following placement of a split-thickness skin graft. When used as an implant beneath a fasciocutaneous flap, healing of the surgical sites was observed after 1–3 months. At the long-term follow-up (3–12 months), all participants had excellent range of motion and none had reported disease recurrences. Conclusion: This pilot case series explored the implementation of an ECM graft as part of the surgical management of axilla Hurley stage III HS. Although the study had a limited number of participants, long-term outcomes were promising and suggest further studies are warranted.
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Affiliation(s)
- Abigail E Chaffin
- Associate Professor of Surgery and Program Director; Department of Surgery, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, Louisiana 70112, US
| | - Marie-Claire Buckley
- Assistant Professor; Department of Surgery, University of Minnesota, School of Medicine, Minneapolis, 55455, US
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Parker MJ, Kim RC, Barrio M, Socas J, Reed LR, Nakeeb A, House MG, Ceppa EP. A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients. Surg Endosc 2020; 35:5173-5178. [PMID: 32970208 DOI: 10.1007/s00464-020-08009-1] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2020] [Accepted: 09/16/2020] [Indexed: 11/25/2022]
Abstract
INTRODUCTION Patients with higher postoperative infection risk undergoing ventral hernia repair (VHR) have limited options for mesh use. Biosynthetic mesh is intended to utilize the durability of synthetic mesh combined with the biocompatibility of biologic mesh. We sought to assess the outcomes of a novel biosynthetic scaffold mesh for VHR in higher risk patients over a 12-month postoperative period. METHODS Two cohorts of 50 consecutive patients who underwent VHR with TELA Bio OviTex biosynthetic or synthetic mesh were retrospectively compared. Endpoints included surgical site occurrence (SSO), readmission rate, and hernia recurrence following VHR at 12 months postoperatively. RESULTS OviTex mesh placement was associated with higher risk Ventral Hernia Working Group (VHWG) distribution and more contaminated CDC wound class distribution compared to synthetic mesh placement (VHWG grade 3: 68% vs. 6%, p < 0.001; CDC class > I: 70% vs. 6%, p < 0.001). Additionally, concomitant procedures were performed more often with OviTex mesh placement than synthetic mesh placement (70% vs 10%, p < 0.001). The OviTex mesh performed comparably to synthetic mesh in terms of incidences of SSO (36% vs 22%, p = 0.19), readmission rates (24% vs 14%, p = 0.31), and hernia recurrence (6% vs 12%, p = 0.74). On further evaluation, patients who developed SSO with OviTex mesh (n = 18) had a 17% hernia recurrence whereas those with synthetic mesh (n = 11) had an associated 55% hernia recurrence (p = 0.048). CONCLUSIONS The OviTex biosynthetic mesh was used in higher risk patients and performed similarly to synthetic mesh in regards to rate of SSO, readmissions, and hernia recurrence. Furthermore, patients who developed SSO with Ovitex mesh were significantly less likely to have hernia recurrence than those with synthetic mesh. Overall, the data suggest that biosynthetic mesh is a more desirable option for definitive hernia repair in higher risk patients.
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Affiliation(s)
- Mitchell J Parker
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Rachel C Kim
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Martin Barrio
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Juan Socas
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Lawrence R Reed
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Attila Nakeeb
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Michael G House
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA
| | - Eugene P Ceppa
- Department of Surgery, Indiana University School of Medicine, 545 Barnhill Dr., EH541, Indianapolis, IN, 46202, USA.
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A novel chemotactic factor derived from the extracellular matrix protein decorin recruits mesenchymal stromal cells in vitro and in vivo. PLoS One 2020; 15:e0235784. [PMID: 32658899 PMCID: PMC7357784 DOI: 10.1371/journal.pone.0235784] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2020] [Accepted: 06/22/2020] [Indexed: 12/20/2022] Open
Abstract
Soft tissue is composed of cells surrounded by an extracellular matrix that is made up of a diverse array of intricately organized proteins. These distinct components work in concert to maintain homeostasis and respond to tissue damage. During tissue repair, extracellular matrix proteins and their degradation products are known to influence physiological processes such as angiogenesis and inflammation. In this study we developed a discovery platform using a decellularized extracellular matrix biomaterial to identify new chemotrophic factors derived from the extracellular matrix. An in vitro culture of RAW.264 macrophage cells with the biomaterial ovine forestomach matrix led to the identification of a novel ~12 kDa chemotactic factor, termed ‘MayDay’, derived from the N-terminal 31–188 sequence of decorin. The recombinant MayDay protein was shown to be a chemotactic agent for mesenchymal stromal cells in vitro and in vivo. We hypothesize that the macrophage-induced cleavage of decorin, via MMP-12, leads to the release of the chemotactic molecule MayDay, that in turn recruits cells to the site of damaged tissue.
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Lake SP, Stoikes NF, Badhwar A, Deeken CR. Contamination of hybrid hernia meshes compared to bioresorbable Phasix™ Mesh in a rabbit subcutaneous implant inoculation model. Ann Med Surg (Lond) 2019; 46:12-16. [PMID: 31467674 PMCID: PMC6710816 DOI: 10.1016/j.amsu.2019.08.004] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2019] [Revised: 07/12/2019] [Accepted: 08/09/2019] [Indexed: 02/06/2023] Open
Abstract
Background Hybrid hernia meshes combine biological tissue-derived extracellular matrix with permanent or resorbable synthetic. The objective of this study was to evaluate hybrid meshes (Gore® Synecor, Zenapro™, Ovitex™ 1S Reinforced Bioscaffold Permanent, and Ovitex™ 1S Reinforced Bioscaffold Resorbable) compared to non-hybrid, bioresorbable synthetic mesh (Phasix™ Mesh) in a rabbit bacterial inoculation model. Materials and methods Subcutaneous pockets were bilaterally created in male, New Zealand White rabbits (n = 25). Circular meshes (3.8 cm diameter) were implanted and inoculated with 1 × 106 colony forming units (CFU) of clinically-isolated methicillin-resistant Staphylococcus aureus (MRSA). A given animal received a single mesh type. Seven days post-inoculation, animals were euthanized and white material and microbial colonization were assessed by abscess scoring and CFU quantification, respectively. Non-parametric Kruskal-Wallis with Dunn's post-hoc tests compared results for different meshes. Results Phasix™ Mesh and Synecor exhibited significantly lower abscess scores than Zenapro™, Ovitex™ 1S Permanent, and Ovitex™ 1S Resorbable (p < 0.05). All pocket swabs for Zenapro™ and Ovitex™ meshes were positive for MRSA (100%), with 20% of Synecor and 0% Phasix™ Mesh. Microbial colonization was significantly lower for Phasix™ Mesh (0 CFU) relative to Zenapro™ (6.73 × 107 CFU (median)), Ovitex™ 1S Permanent (7.87 × 107 CFU) and Ovitex™ 1S Resorbable (1.45 × 108 CFU), and for Synecor (0 CFU) relative to both Ovitex™ meshes. Phasix™ Mesh was the only device with no detectable abscess or microbial colonization. Conclusion Phasix™ Mesh demonstrated no detectable abscess or microbial colonization at 7-days post-implantation and inoculation, in contrast with four hybrid meshes, which all demonstrated colonization in a rabbit bacterial inoculation model.
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Affiliation(s)
- Spencer P. Lake
- Department of Mechanical Engineering & Materials Science, Washington University in St. Louis, St. Louis, MO, USA
| | | | - Amit Badhwar
- C.R. Bard/Davol. Inc., Warwick, RI, USA
- Corresponding author. 100 Crossings Boulevard, Warwick, RI, 02886, USA.
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Costa A, Adamo S, Gossetti F, D'Amore L, Ceci F, Negro P, Bruzzone P. Biological Scaffolds for Abdominal Wall Repair: Future in Clinical Application? MATERIALS 2019; 12:ma12152375. [PMID: 31349716 PMCID: PMC6695954 DOI: 10.3390/ma12152375] [Citation(s) in RCA: 33] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/24/2019] [Revised: 07/22/2019] [Accepted: 07/24/2019] [Indexed: 12/11/2022]
Abstract
Millions of abdominal wall repair procedures are performed each year for primary and incisional hernias both in the European Union and in the United States with extremely high costs. Synthetic meshes approved for augmenting abdominal wall repair provide adequate mechanical support but have significant drawbacks (seroma formation, adhesion to viscera, stiffness of abdominal wall, and infection). Biologic scaffolds (i.e., derived from naturally occurring materials) represent an alternative to synthetic surgical meshes and are less sensitive to infection. Among biologic scaffolds, extracellular matrix scaffolds promote stem/progenitor cell recruitment in models of tissue remodeling and, in the specific application of abdominal wall repair, have enough mechanical strength to support the repair. However, many concerns remain about the use of these scaffolds in the clinic due to their higher cost of production compared with synthetic meshes, despite having the same recurrence rate. The present review aims to highlight the pros and cons of using biologic scaffolds as surgical devices for abdominal wall repair and present possible improvements to widen their use in clinical practice.
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Affiliation(s)
- Alessandra Costa
- Sezione di Istologia ed Embriologia Medica, Dipartimento SAIMLAL, Sapienza Università di Roma, Via A. Scarpa 16, 00161 Rome, Italy
| | - Sergio Adamo
- Sezione di Istologia ed Embriologia Medica, Dipartimento SAIMLAL, Sapienza Università di Roma, Via A. Scarpa 16, 00161 Rome, Italy
| | - Francesco Gossetti
- Dipartimento Assistenziale Integrato Cardio Toraco-Vascolare, Chirurgia e Trapianti d'Organo, Azienda Ospedaliera Universitaria Policlinico Umberto I. Dipartimento Universitario Chirurgia Generale e Specialistica "Paride Stefanini", Sapienza Università di Roma, Viale del Policlinico 155, 00161 Rome, Italy
| | - Linda D'Amore
- Dipartimento Assistenziale Integrato Cardio Toraco-Vascolare, Chirurgia e Trapianti d'Organo, Azienda Ospedaliera Universitaria Policlinico Umberto I. Dipartimento Universitario Chirurgia Generale e Specialistica "Paride Stefanini", Sapienza Università di Roma, Viale del Policlinico 155, 00161 Rome, Italy
| | - Francesca Ceci
- Dipartimento Assistenziale Integrato Cardio Toraco-Vascolare, Chirurgia e Trapianti d'Organo, Azienda Ospedaliera Universitaria Policlinico Umberto I. Dipartimento Universitario Chirurgia Generale e Specialistica "Paride Stefanini", Sapienza Università di Roma, Viale del Policlinico 155, 00161 Rome, Italy
| | - Paolo Negro
- Dipartimento Assistenziale Integrato Cardio Toraco-Vascolare, Chirurgia e Trapianti d'Organo, Azienda Ospedaliera Universitaria Policlinico Umberto I. Dipartimento Universitario Chirurgia Generale e Specialistica "Paride Stefanini", Sapienza Università di Roma, Viale del Policlinico 155, 00161 Rome, Italy
| | - Paolo Bruzzone
- Dipartimento Assistenziale Integrato Cardio Toraco-Vascolare, Chirurgia e Trapianti d'Organo, Azienda Ospedaliera Universitaria Policlinico Umberto I. Dipartimento Universitario Chirurgia Generale e Specialistica "Paride Stefanini", Sapienza Università di Roma, Viale del Policlinico 155, 00161 Rome, Italy.
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Dempsey SG, Miller CH, Hill RC, Hansen KC, May BCH. Functional Insights from the Proteomic Inventory of Ovine Forestomach Matrix. J Proteome Res 2019; 18:1657-1668. [DOI: 10.1021/acs.jproteome.8b00908] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Affiliation(s)
- Sandi G. Dempsey
- Aroa Biosurgery Limited, Airport Oaks, Auckland 2022, New Zealand
| | | | - Ryan C. Hill
- Omix Technologies LLC, Bioscience 1, 12635 E. Montview Blvd. Suite 100, Aurora, Colorado 80045, United States
| | - Kirk C. Hansen
- Omix Technologies LLC, Bioscience 1, 12635 E. Montview Blvd. Suite 100, Aurora, Colorado 80045, United States
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