LAUSR

BACKGROUND An aseptically processed dehydrated human amnion and chorion allograft(dHACA) without terminal sterilization has been shown to improve healing rates in chronic wounds. This randomized controlled trial(RCT) evaluated the safety and effectiveness of weekly and biweekly applications of dHACA plus Standard of Care (SOC) compared to SOC alone on chronic venous leg ulcers (VLUs). METHODS This open-label RCT included patients with chronic VLUs at 8 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% closure at 4 weeks and the incidence of adverse events (AEs). RESULTS Among 101 patients screened for eligibility, 60 were eligible and enrolled. At 12 weeks, significantly more VLUs healed in the two dHACA-treated groups (30/40, 75%) than in the SOC group (6/20, 30%), p = 0.001. Treatment with dHACA remained significant after adjustment for wound area (p = 0.002), with an odds ratio of 8.7 (95% confidence interval: 2.2-33.6). Only six VLUs (30%) healed in the SOC group compared to 15 (75%) in the weekly dHACA group (p = 0.02) and 15 (75%) in the biweekly dHACA group (p =0.02). There were no significant differences in the proportion of wounds with percent area reduction (PAR ) ≥40% at 4 weeks among all groups. The AE rate was 63.5%. Among the 38 AEs, none were graft- or procedure-related, and all were resolved with appropriate treatment. CONCLUSIONS The adjunctive treatment of chronic VLUs with dHACA and SOC, regardless of weekly or biweekly application, significantly healed more VLUs than SOC alone, suggesting that the use of aseptically processed dHACA is advantageous as well as a safe and effective treatment option in the healing of chronic VLUs.