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A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers
A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing full‐thickness venous leg ulcers. We randomly assigned 109 subje...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949978/ https://www.ncbi.nlm.nih.gov/pubmed/29024419 http://dx.doi.org/10.1111/iwj.12843 |
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author | Bianchi, Christian Cazzell, Shawn Vayser, Dean Reyzelman, Alexander M Dosluoglu, Hasan Tovmassian, Gregory |
author_facet | Bianchi, Christian Cazzell, Shawn Vayser, Dean Reyzelman, Alexander M Dosluoglu, Hasan Tovmassian, Gregory |
author_sort | Bianchi, Christian |
collection | PubMed |
description | A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing full‐thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan–Meier analysis was performed to compare the time‐to‐healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log‐rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25–4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing, full‐thickness venous leg ulcers. |
format | Online Article Text |
id | pubmed-7949978 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-79499782021-07-02 A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers Bianchi, Christian Cazzell, Shawn Vayser, Dean Reyzelman, Alexander M Dosluoglu, Hasan Tovmassian, Gregory Int Wound J Original Articles A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing full‐thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan–Meier analysis was performed to compare the time‐to‐healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log‐rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25–4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing, full‐thickness venous leg ulcers. Blackwell Publishing Ltd 2017-10-11 /pmc/articles/PMC7949978/ /pubmed/29024419 http://dx.doi.org/10.1111/iwj.12843 Text en © 2017 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Bianchi, Christian Cazzell, Shawn Vayser, Dean Reyzelman, Alexander M Dosluoglu, Hasan Tovmassian, Gregory A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers |
title | A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers |
title_full | A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers |
title_fullStr | A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers |
title_full_unstemmed | A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers |
title_short | A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix(®)) allograft for the treatment of venous leg ulcers |
title_sort | multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (epifix(®)) allograft for the treatment of venous leg ulcers |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7949978/ https://www.ncbi.nlm.nih.gov/pubmed/29024419 http://dx.doi.org/10.1111/iwj.12843 |
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