Bianchi C, Cazzell S, Vayser D, Reyzelman AM, Dosluoglu H, Tovmassian G, EpiFix VLU Study Group., et al.
International wound journal. Date of publication 2018 Feb 1;volume 15(1):114-122.
1. Int Wound J. 2018 Feb;15(1):114-122. doi: 10.1111/iwj.12843. Epub 2017 Oct 11.
A multicentre randomised controlled trial evaluating the efficacy of dehydrated
human amnion/chorion membrane (EpiFix® ) allograft for the treatment of venous
leg ulcers.
Bianchi C(1), Cazzell S(2), Vayser D(3), Reyzelman AM(4), Dosluoglu H(5),
Tovmassian G(6); EpiFix VLU Study Group.
Author information:
(1)Department of Surgery, Loma Linda University Medical Center, Loma Linda, CA,
USA.
(2)Limb Preservation Platform, Inc, Fresno, CA, USA.
(3)ILD Research Center, San Diego, CA, USA.
(4)Center for Clinical Research, Inc, San Francisco, CA, USA.
(5)VA Western New York Healthcare System, Buffalo, NY, USA.
(6)Center for Clinical Research, Inc. Sacramento Foot and Ankle Center,
Sacramento, CA, USA.
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.
© 2017 The Authors. International Wound Journal published by Medicalhelplines.com
Inc and John Wiley & Sons Ltd.
DOI: 10.1111/iwj.12843
PMID: 29024419 [Indexed for MEDLINE]
