A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix^®) allograft for the treatment of venous leg ulcers

Abstract

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.

Characterisation of dehydrated amnion chorion membranes and evaluation of fibroblast and keratinocyte responses in vitro

“…Placental membranes have a long documented history as being used to treat both chronic and acute wounds . Clinical studies of placental membranes have demonstrated improved outcomes in a variety of wound types, including: acute wounds, DFUs, and venous leg ulcers . Placental tissues are processed in various ways, including: cryopreservation, hypothermic storage, and dehydration .…”

Effects of acellular equine amniotic allografts on the healing of experimentally induced full‐thickness distal limb wounds in horses

“…They have consequently been investigated as a biological source for scaffolds . Amniotic scaffolds have been produced after extensive processing and decellularization techniques to address concerns regarding transmissible diseases in human medicine . Amniotic scaffolds can also be dehydrated, thereby allowing sterilization with gamma irradiation .…”

Variations in study outcomes relative to intention‐to‐treat and per‐protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft

“…There were 128 patients randomised and included in the ITT population: 64 to the EpiFix group and 64 to the standard care group. The PP population reported in the prior manuscript was comprised of 109 subjects: 52 received EpiFix, and 57 received standard care . Data from 19 randomised subjects, 12 from the EpiFix group and 7 controls, were not included in the published report .…”

“…The confidentiality of all patient records was maintained. Complete details of the study methods can be found in the previously published paper …”

“…A recent multicentre RCT by Bianchi et al examined the use of a commercially available dehydrated human amnion/chorion membrane allograft (EpiFix, MiMedx Group Inc., Marietta, Georgia) as a treatment for chronic VLU. That study reported results on only those 109 subjects completing the study PP.…”