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.
Plast Reconstr Surg. 2022 Nov 1;150(5):1128-1136. doi: 10.1097/PRS.0000000000009650. Epub 2022 Sep 2.
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.
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.
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.
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.
本随机对照试验评估了每周和每两周应用脱水人羊膜和绒毛膜同种异体移植物（dHACA）联合标准护理与单独标准护理相比治疗慢性静脉性腿部溃疡的安全性和有效性。
本开放性标签随机对照试验纳入了美国 8 个伤口护理中心的慢性静脉性腿部溃疡患者。主要终点是 12 周时溃疡愈合的比例。次要终点包括 4 周时溃疡达到 40%闭合的比例和不良事件的发生率。
在筛选出的 101 名符合条件的患者中，有 60 名符合条件并被纳入。在 12 周时，与标准护理组（30%）相比，两个 dHACA 治疗组（75%）的静脉性腿部溃疡愈合比例显著更高（p=0.001），即使调整了伤口面积（p=0.002），优势比为 8.7（95%CI，2.2 至 33.6）。在所有组中，4 周时比例大于或等于 40%的伤口面积减少的比例没有显著差异。不良事件发生率为 63.5%。在 38 起不良事件中，无一起与移植物或手术相关，所有不良事件均通过适当治疗得到解决。
与单独标准护理相比，dHACA 和标准护理，无论是每周还是每两周应用，均显著治愈了更多的静脉性腿部溃疡，这表明使用无菌处理的 dHACA 在慢性静脉性腿部溃疡的愈合方面是有利的，是一种安全有效的治疗选择。
临床问题/证据水平：治疗性，I 级。
