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Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement
BACKGROUND: Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The safety and effectiveness of a long-lasting, transi...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255889/ https://www.ncbi.nlm.nih.gov/pubmed/25506529 http://dx.doi.org/10.1097/GOX.0000000000000217 |
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author | Clemens, Mark W. Downey, Susan Agullo, Frank Lehfeldt, Max R. Kind, Gabriel M. Palladino, Humberto Marshall, Deirdre Jewell, Mark L. Mathur, Anshu B. Bengtson, Bradley P. |
author_facet | Clemens, Mark W. Downey, Susan Agullo, Frank Lehfeldt, Max R. Kind, Gabriel M. Palladino, Humberto Marshall, Deirdre Jewell, Mark L. Mathur, Anshu B. Bengtson, Bradley P. |
author_sort | Clemens, Mark W. |
collection | PubMed |
description | BACKGROUND: Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The safety and effectiveness of a long-lasting, transitory, 510(k)-cleared purified silk fibroin biologic scaffold (SBS) are investigated for soft-tissue support and repair of the abdominal wall. METHODS: We conducted a multicenter retrospective review of all consecutive patients who underwent abdominal wall soft-tissue reinforcement with an SBS device between 2011 and 2013. Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated. RESULTS: We reviewed the records of 172 consecutive patients who received an SBS for soft-tissue support. Of those, 77 patients underwent abdominal wall fascial repair, with a mean follow-up of 18.4 ± 7.5 months. Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%). The overall complication rate was 6.5%, consisting of 2 wound dehiscences, 1 with device exposure, 1 seroma, 1 infection with explantation, and a perioperative bulge requiring reoperation. There were no reports of hernia. CONCLUSIONS: Postoperative complication rates after 18 months were low, and most surgical complications were managed nonoperatively on an outpatient basis without mesh removal. To our knowledge, this is the only series to report on a long-lasting, transitory SBS for abdominal wall repair and reinforcement. Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages. |
format | Online Article Text |
id | pubmed-4255889 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-42558892014-12-12 Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement Clemens, Mark W. Downey, Susan Agullo, Frank Lehfeldt, Max R. Kind, Gabriel M. Palladino, Humberto Marshall, Deirdre Jewell, Mark L. Mathur, Anshu B. Bengtson, Bradley P. Plast Reconstr Surg Glob Open Original Articles BACKGROUND: Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The safety and effectiveness of a long-lasting, transitory, 510(k)-cleared purified silk fibroin biologic scaffold (SBS) are investigated for soft-tissue support and repair of the abdominal wall. METHODS: We conducted a multicenter retrospective review of all consecutive patients who underwent abdominal wall soft-tissue reinforcement with an SBS device between 2011 and 2013. Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated. RESULTS: We reviewed the records of 172 consecutive patients who received an SBS for soft-tissue support. Of those, 77 patients underwent abdominal wall fascial repair, with a mean follow-up of 18.4 ± 7.5 months. Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%). The overall complication rate was 6.5%, consisting of 2 wound dehiscences, 1 with device exposure, 1 seroma, 1 infection with explantation, and a perioperative bulge requiring reoperation. There were no reports of hernia. CONCLUSIONS: Postoperative complication rates after 18 months were low, and most surgical complications were managed nonoperatively on an outpatient basis without mesh removal. To our knowledge, this is the only series to report on a long-lasting, transitory SBS for abdominal wall repair and reinforcement. Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages. Wolters Kluwer Health 2014-12-05 /pmc/articles/PMC4255889/ /pubmed/25506529 http://dx.doi.org/10.1097/GOX.0000000000000217 Text en Copyright © 2014 The Authors. Published by Lippincott Williams & Wilkins on behalf of The American Society of Plastic Surgeons. PRS Global Open is a publication of the American Society of Plastic Surgeons. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. |
spellingShingle | Original Articles Clemens, Mark W. Downey, Susan Agullo, Frank Lehfeldt, Max R. Kind, Gabriel M. Palladino, Humberto Marshall, Deirdre Jewell, Mark L. Mathur, Anshu B. Bengtson, Bradley P. Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement |
title | Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement |
title_full | Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement |
title_fullStr | Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement |
title_full_unstemmed | Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement |
title_short | Clinical Application of a Silk Fibroin Protein Biologic Scaffold for Abdominal Wall Fascial Reinforcement |
title_sort | clinical application of a silk fibroin protein biologic scaffold for abdominal wall fascial reinforcement |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4255889/ https://www.ncbi.nlm.nih.gov/pubmed/25506529 http://dx.doi.org/10.1097/GOX.0000000000000217 |
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