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Cho M, Shim KM, Park SS, Kang SS, Jang K, Kim SE. Evaluation of Biocompatibility and Healing Properties of Dural Substitutes Produced by Electrospinning Technology. In Vivo 2024; 38:1119-1126. [PMID: 38688638 PMCID: PMC11059857 DOI: 10.21873/invivo.13546] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2023] [Revised: 12/13/2023] [Accepted: 12/14/2023] [Indexed: 05/02/2024]
Abstract
BACKGROUND/AIM Dural reconstruction is a critical process after neurosurgical procedures. Improper dural repair leads to serious side-effects, such as cerebrospinal fluid leakage or infection. This is why it is important to properly repair the dura using a dural substitute, and research into dural substitutes is ongoing. The ideal dural substitute should be non-toxic, biocompatible, and capable of maintaining adequate tension and preventing cerebrospinal fluid leakage for extended periods in vivo. This study evaluated the biocompatibility and healing properties of Safe-Seal, poly-L-lactic acid synthetic bioabsorbable dural substitute produced by electrospinning technology. MATERIALS AND METHODS Safe-Seal, was created by electrospinning, which is a technique for nanofiberizing polymers into three-dimensional structures, and its cytotoxicity was evaluated. The animal study used 30 rats, divided into three groups assessed at two time points (4 and 12 weeks). The study groups were a negative control group with no treatment, an experimental group with Safe-Seal (TDM Co. Ltd., Gwangju, Republic of Korea) implantation, and a positive control group with a commercial product, Redura® (Medprin Biotech, Frankfurt, Germany) implantation. RESULTS Safe-Seal exhibited no cytotoxic or adverse effects in the in vivo animal study. Histologically, Safe-Seal displayed less inflammatory cell infiltration, less adhesion to brain tissue, and connectivity with the surrounding dura mater as compared to the negative control group and without any significant differences from Redura® in all evaluation criteria. CONCLUSION Safe-Seal presented adequate biocompatibility in vivo and contributed to the healing of the dura mater at a similar level to that of Redura® when applied to dural defects.
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Affiliation(s)
- Minjoo Cho
- College of Veterinary Medicine and BK21 Four Program, Chonnam National University, Gwangju, Republic of Korea
- Biomaterial R&BD Center, Chonnam National University, Gwangju, Republic of Korea
| | - Kyung Mi Shim
- College of Veterinary Medicine and BK21 Four Program, Chonnam National University, Gwangju, Republic of Korea
- Biomaterial R&BD Center, Chonnam National University, Gwangju, Republic of Korea
| | | | - Seong Soo Kang
- College of Veterinary Medicine and BK21 Four Program, Chonnam National University, Gwangju, Republic of Korea
- Biomaterial R&BD Center, Chonnam National University, Gwangju, Republic of Korea
| | - Kwangsik Jang
- College of Veterinary Medicine and BK21 Four Program, Chonnam National University, Gwangju, Republic of Korea;
- Biomaterial R&BD Center, Chonnam National University, Gwangju, Republic of Korea
| | - Se Eun Kim
- College of Veterinary Medicine and BK21 Four Program, Chonnam National University, Gwangju, Republic of Korea;
- Biomaterial R&BD Center, Chonnam National University, Gwangju, Republic of Korea
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King NC, Guastaldi FPS, Khanna AR, Redmond RW, Winograd JM. Photosealing of dural defects using a biocompatible patch. Acta Neurochir (Wien) 2023; 165:2293-2298. [PMID: 37284839 DOI: 10.1007/s00701-023-05653-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2023] [Accepted: 05/27/2023] [Indexed: 06/08/2023]
Abstract
PURPOSE Photosealing of many biological tissues can be achieved using a biocompatible material in combination with a dye that is activated by visible light to chemically bond over the tissue defect via protein cross-linking reactions. The aim of this study was to test the efficacy of photosealing using a commercially available biomembrane (AmnioExcel Plus) to securely close dural defects in comparison to another sutureless method (fibrin glue) in terms of repair strength. METHODS Two-millimeter diameter holes were created in dura harvested from New Zealand white rabbits and repaired ex vivo using one of two methods: (1) in n = 10 samples, photosealing was used to bond a 6-mm-diameter AmnioExcel Plus patch over the dural defect, and (2) in n = 10 samples, fibrin glue was used to attach the same patch over the dural defect. Repaired dura samples were then subjected to burst pressure testing. Histological analysis was also performed of photosealed dura. RESULTS The mean burst pressures of rabbit dura repaired with photosealing and fibrin glue were 302 ± 149 mmHg and 26 ± 24 mmHg, respectively. The increased repair strength using photosealing was statistically significant and considerably higher than the normal intracranial pressure of ~ 20 mmHg. Histology demonstrated a tight union at the interface between the dura surface and patch with no disruption of the dura structure. CONCLUSION The results of this study suggest that photosealing performs better than fibrin glue for the fixation of a patch for ex vivo repair of small dural defects. Photosealing is worthy of testing in pre-clinical models for the repair of dural defects.
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Affiliation(s)
- Nicholas C King
- Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital, Harvard Medical School, 15 Parkman Street, WACC 435, Boston, MA, 02114, USA
- Boston University School of Medicine, Boston, MA, USA
| | - Fernando P S Guastaldi
- Department of Oral and Maxillofacial Surgery, Massachusetts General Hospital, Harvard School of Dental Medicine, Boston, MA, USA
| | - Arjun R Khanna
- Department of Neurosurgery, Massachusetts General Hospital, Boston, MA, USA
| | - Robert W Redmond
- Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
| | - Jonathan M Winograd
- Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital, Harvard Medical School, 15 Parkman Street, WACC 435, Boston, MA, 02114, USA.
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Dong RP, Zhang Q, Yang LL, Cheng XL, Zhao JW. Clinical management of dural defects: A review. World J Clin Cases 2023; 11:2903-2915. [PMID: 37215425 PMCID: PMC10198091 DOI: 10.12998/wjcc.v11.i13.2903] [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: 12/28/2022] [Revised: 03/03/2023] [Accepted: 04/04/2023] [Indexed: 04/25/2023] Open
Abstract
Dural defects are common in spinal and cranial neurosurgery. A series of complications, such as cerebrospinal fluid leakage, occur after rupture of the dura. Therefore, treatment strategies are necessary to reduce or avoid complications. This review comprehensively summarizes the common causes, risk factors, clinical complications, and repair methods of dural defects. The latest research progress on dural repair methods and materials is summarized, including direct sutures, grafts, biomaterials, non-biomaterial materials, and composites formed by different materials. The characteristics and efficacy of these dural substitutes are reviewed, and these materials and methods are systematically evaluated. Finally, the best methods for dural repair and the challenges and future prospects of new dural repair materials are discussed.
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Affiliation(s)
- Rong-Peng Dong
- Department of Spinal Surgery, The Second Hospital of Jilin University, Changchun 130000, Jilin Province, China
| | - Qi Zhang
- Department of Spinal Surgery, The Second Hospital of Jilin University, Changchun 130000, Jilin Province, China
| | - Li-Li Yang
- Department of Spinal Surgery, The Second Hospital of Jilin University, Changchun 130000, Jilin Province, China
| | - Xue-Liang Cheng
- Department of Spinal Surgery, The Second Hospital of Jilin University, Changchun 130000, Jilin Province, China
| | - Jian-Wu Zhao
- Department of Spinal Surgery, The Second Hospital of Jilin University, Changchun 130000, Jilin Province, China
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Lipovka A, Kharchenko A, Dubovoy A, Filipenko M, Stupak V, Mayorov A, Fomenko V, Geydt P, Parshin D. The Effect of Adding Modified Chitosan on the Strength Properties of Bacterial Cellulose for Clinical Applications. Polymers (Basel) 2021; 13:1995. [PMID: 34207113 PMCID: PMC8234744 DOI: 10.3390/polym13121995] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2021] [Revised: 06/11/2021] [Accepted: 06/13/2021] [Indexed: 12/01/2022] Open
Abstract
Currently, several materials for the closure of the dura mater (DM) defects are known. However, the long-term results of their usage reveal a number of disadvantages. The use of antibiotics and chitosan is one of the major trends in solving the problems associated with infectious after-operational complications. This work compares the mechanical properties of samples of bacterial nanocellulose (BNC) impregnated with Novochizol™ and vancomycin with native BNC and preserved and native human DM. An assessment of the possibility of controling the mechanical properties of these materials by changing their thickness has been performed by statistical analysis methods. A total of 80 specimens of comparable samples were investigated. During the analysis, the results obtained, the factor of Novochizol™ addition has provided a statistically significant impact on the strength properties (Fisher Criteria p-value 0.00509 for stress and 0.00112 for deformation). Moreover, a stronger relationship between the thickness of the samples and their ultimate load was shown: R2=0.236 for BNC + Novochizol™ + vancomycin, compared to R2=0.0405 for native BNC. Using factor analysis, it was possible to show a significant effect of modified chitosan (Novochizol™) on the ultimate stress (p-value = 0.005).
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Affiliation(s)
- Anna Lipovka
- Lavrentyev Institute of Hydrodynamics of the Siberian Branch of the Russian Academy of Sciences, 630090 Novosibirsk, Russia; (A.D.); (D.P.)
| | - Alexey Kharchenko
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, 630090 Novosibirsk, Russia; (A.K.); (V.S.)
| | - Andrey Dubovoy
- Lavrentyev Institute of Hydrodynamics of the Siberian Branch of the Russian Academy of Sciences, 630090 Novosibirsk, Russia; (A.D.); (D.P.)
- Federal Neurosurgical Center, 630048 Novosibirsk, Russia
| | - Maxim Filipenko
- Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences, 630090 Novosibirsk, Russia;
| | - Vyacheslav Stupak
- Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan, 630090 Novosibirsk, Russia; (A.K.); (V.S.)
| | - Alexander Mayorov
- Institute of Laser Physics of the Russian Academy of Sciences, 630090 Novosibirsk, Russia;
| | - Vladislav Fomenko
- N.N. Vorozhtsov Novosibirsk Institute of Organic Chemistry of the Russian Academy of Sciences, 630090 Novosibirsk, Russia;
| | - Pavel Geydt
- Novosibirsk State University, 630090 Novosibirsk, Russia;
| | - Daniil Parshin
- Lavrentyev Institute of Hydrodynamics of the Siberian Branch of the Russian Academy of Sciences, 630090 Novosibirsk, Russia; (A.D.); (D.P.)
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Liu W, Wang X, Su J, Jiang Q, Wang J, Xu Y, Zheng Y, Zhong Z, Lin H. In vivo Evaluation of Fibrous Collagen Dura Substitutes. Front Bioeng Biotechnol 2021; 9:628129. [PMID: 33681163 PMCID: PMC7930396 DOI: 10.3389/fbioe.2021.628129] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2020] [Accepted: 01/29/2021] [Indexed: 02/05/2023] Open
Abstract
Dura substitutes are applied in duraplasty to repair lost or damaged dura. Collagen-based dura substitutes are mainstream products in both the US and Chinese markets. In this study, dura substitute devices with potential dura regeneration ability are evaluated. The dura substitutes are composed of fibrous type I collagen that were purified from bovine tendon. Physical and chemical characterization demonstrated that the tested dura substitute has desirable porous scaffolding structures and is composed of highly purified type I collagen. The collagen dura substitutes were further investigated in vivo with a rabbit model for 6 months to evaluate their safety and performance to repair and regenerate dura. No inflammation or infection was observed during the course of in vivo study. The integration of the collagen dura substitutes with surrounding tissue was normal as compared to native tissue. The macroscopic and microscopic histological assessments of the sampled animal tissue showed that the damaged dura were regenerated. The collagen dura substitutes were resorbed between 3 and 6 months along with newly regenerated dura. Both tissue adhesion and dura repair was the worst in blank control group as compared to those in the collagen dura substitutes. Taken together, regenerative collagen dura substitutes demonstrated with suitable physicochemical properties. The in vivo evaluation in a rabbit model further demonstrated the safety and performance of such substitutes for dura repair and regeneration.
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Affiliation(s)
- Wenbo Liu
- School of Material Science and Engineering, University of Science and Technology Beijing, Beijing, China
| | - Xin Wang
- Laboratory of Nonhuman Primate Disease Modeling Research, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China
| | - Jinlei Su
- National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China
| | - Qingsong Jiang
- National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China
| | - Jing Wang
- National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China
| | - Yang Xu
- National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China
| | - Yudong Zheng
- School of Material Science and Engineering, University of Science and Technology Beijing, Beijing, China
| | - Zhihui Zhong
- Laboratory of Nonhuman Primate Disease Modeling Research, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China
| | - Hai Lin
- National Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China
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Edmans JG, Clitherow KH, Murdoch C, Hatton PV, Spain SG, Colley HE. Mucoadhesive Electrospun Fibre-Based Technologies for Oral Medicine. Pharmaceutics 2020; 12:E504. [PMID: 32498237 PMCID: PMC7356016 DOI: 10.3390/pharmaceutics12060504] [Citation(s) in RCA: 34] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2020] [Revised: 05/28/2020] [Accepted: 05/30/2020] [Indexed: 02/07/2023] Open
Abstract
Oral disease greatly affects quality of life, as the mouth is required for a wide range of activities including speech, food and liquid consumption. Treatment of oral disease is greatly limited by the dose forms that are currently available, which suffer from short contact times, poor site specificity, and sensitivity to mechanical stimulation. Mucoadhesive devices prepared using electrospinning offer the potential to address these challenges by allowing unidirectional site-specific drug delivery through intimate contact with the mucosa and with high surface areas to facilitate drug release. This review will discuss the range of electrospun mucoadhesive devices that have recently been reported to address oral inflammatory diseases, pain relief, and infections, as well as new treatments that are likely to be enabled by this technology in the future.
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Affiliation(s)
- Jake G. Edmans
- School of Clinical Dentistry, 19 Claremont Crescent, University of Sheffield, Sheffield S10 2TA, UK; (J.G.E.); (K.H.C.); (P.V.H.); (H.E.C.)
- Department of Chemistry, Brook Hill, University of Sheffield, Sheffield S3 7HF, UK;
| | - Katharina H. Clitherow
- School of Clinical Dentistry, 19 Claremont Crescent, University of Sheffield, Sheffield S10 2TA, UK; (J.G.E.); (K.H.C.); (P.V.H.); (H.E.C.)
- Department of Chemistry, Brook Hill, University of Sheffield, Sheffield S3 7HF, UK;
| | - Craig Murdoch
- School of Clinical Dentistry, 19 Claremont Crescent, University of Sheffield, Sheffield S10 2TA, UK; (J.G.E.); (K.H.C.); (P.V.H.); (H.E.C.)
| | - Paul V. Hatton
- School of Clinical Dentistry, 19 Claremont Crescent, University of Sheffield, Sheffield S10 2TA, UK; (J.G.E.); (K.H.C.); (P.V.H.); (H.E.C.)
| | - Sebastian G. Spain
- Department of Chemistry, Brook Hill, University of Sheffield, Sheffield S3 7HF, UK;
| | - Helen E. Colley
- School of Clinical Dentistry, 19 Claremont Crescent, University of Sheffield, Sheffield S10 2TA, UK; (J.G.E.); (K.H.C.); (P.V.H.); (H.E.C.)
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