Serena TE, Orgill DP, Armstrong DG, Galiano RD, Glat PM, Carter MJ, Kaufman JP, Li WW, Zelen CM, et al.
Plastic and reconstructive surgery. Date of publication 2022 Nov 1;volume 150(5):1128-1136.
1. Plast Reconstr Surg. 2022 Nov 1;150(5):1128-1136. doi:
10.1097/PRS.0000000000009650. Epub 2022 Sep 2.
A Multicenter, Randomized, Controlled, Clinical Trial Evaluating Dehydrated
Human Amniotic Membrane in the Treatment of Venous Leg Ulcers.
Serena TE(1), Orgill DP(1), Armstrong DG(1), Galiano RD(1), Glat PM(1), Carter
MJ(1), Kaufman JP(1), Li WW(1), Zelen CM(1).
Author information:
(1)From the Serena Groups; Brigham and Women's Hospital; University of Southern
California, Keck School of Medicine; Northwestern University School of Medicine;
Drexel University School of Medicine; Strategic Solutions; Department of
Surgery, Temple University School of Medicine, and McGowan Institute for
Regenerative Medicine, University of Pittsburgh; Angiogenesis Foundation; and
Professional Education and Research Institute.
BACKGROUND: This randomized controlled trial evaluated the safety and
effectiveness of weekly and biweekly applications of dehydrated human amnion and
chorion allograft (dHACA) plus standard of care compared to standard of care
alone on chronic venous leg ulcers.
METHODS: This open-label randomized controlled trial included patients with
chronic venous leg ulcers at eight wound care centers across the United States.
The primary endpoint was the proportion of healed ulcers at 12 weeks. Secondary
endpoints included the proportion of ulcers achieving 40 percent closure at 4
weeks and the incidence of adverse events.
RESULTS: Among 101 patients screened for eligibility, 60 were eligible and
enrolled. At 12 weeks, significantly more venous leg ulcers healed in the two
dHACA-treated groups (75 percent) than in the standard-of-care group (30
percent) ( p = 0.001) even after adjustment for wound area ( p = 0.002), with an
odds ratio of 8.7 (95 percent CI, 2.2 to 33.6). There were no significant
differences in the proportion of wounds with percentage area reduction greater
than or equal to 40 percent at 4 weeks among all groups. The adverse event rate
was 63.5 percent. Among the 38 adverse events, none were graft or procedure
related, and all were resolved with appropriate treatment.
CONCLUSIONS: dHACA and standard of care, either applied weekly or biweekly,
significantly healed more venous leg ulcers than standard of care alone,
suggesting that the use of aseptically processed dHACA is advantageous and a
safe and effective treatment option in the healing of chronic venous leg ulcers.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf
of the American Society of Plastic Surgeons. All rights reserved.
DOI: 10.1097/PRS.0000000000009650
PMCID: PMC9586828
PMID: 36067479 [Indexed for MEDLINE]
