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Publications library Research article

Plast Reconstr Surg · 2022

A Multicenter, Randomized, Controlled, Clinical Trial Evaluating Dehydrated Human Amniotic Membrane in the Treatment of Venous Leg Ulcers

Serena, T.E., Orgill, D.P., Armstrong, D.G., Galiano, R.D., Glat, P.M., Carter, M.J., Kaufman, J.P., Li, W.W., & Zelen, C.M.

Plastic and Reconstructive Surgery

In brief

In this open-label randomized controlled trial at eight US wound care centers, 60 patients with chronic venous leg ulcers received a dehydrated human amnion and chorion allograft (dHACA) applied weekly or every 2 weeks plus standard care with compression, or standard care alone. At 12 weeks, 75 percent of ulcers healed in the two dHACA groups combined versus 30 percent with standard care alone, a statistically significant difference (p = 0.001), and healing did not differ between weekly and biweekly application; the secondary endpoint of 40 percent area reduction at 4 weeks showed no significant difference between groups. None of the 38 adverse events were judged related to the graft or procedure.

SerenaGroup helped administer this trial, funded by MTF Biologics.

Plain-language summary by SerenaGroup. See the full text for complete methods and results.

No abstract is published for this item. Use the full text link for the complete document.