Efficacy and Safety of Human Amniotic Membrane for Chronic Wounds: A Systematic Review and Meta-Analysis of Clinical Trials

Abstract

Objective:

The meta-analysis was performed to evaluate the efficacy and safety associated with the application of human amniotic membrane (HAM) in individuals with chronic nonhealing wounds.

Approach:

The research conducted a comprehensive search of nine electronic databases from their inception to August 1, 2024, aiming to identify randomized controlled trials (RCTs) that evaluated the efficacy of HAM compared with conventional management alone in individuals suffering from chronic wounds. The risk of bias of included studies and the certainty of the evidence in the meta-analysis were evaluated by two investigators and confirmed by a third. The meta-analysis was performed using RevMan 5.4 software.

Results:

We identified 14 RCTs encompassing a total of 1,056 participants. The potential risk of bias was determined to be moderate. HAM therapy demonstrated significantly greater efficacy than conventional treatment alone in achieving complete wound healing among patients with chronic ulcers (relative risk [RR] = 1.82; 95% confidence interval [CI]: 1.48–2.24; moderate-quality evidence). In patients with diabetic foot ulcers, HAM reduced the mean time to complete healing by 22 days compared with standard care alone (mean difference = −22.09 days; 95% CI: −39.13 to −5.05; low-quality evidence) and increased the rate of complete healing at 6 weeks (RR = 3.02; 95% CI: 2.04–4.47; moderate-quality evidence) and at 12 weeks (RR = 1.74; 95% CI: 1.37–2.21; low-quality evidence). Similarly, in patients with venous leg ulcers, HAM was associated with more than twice the likelihood of complete healing (RR = 2.03; 95% CI: 1.45–2.86; moderate-quality evidence). No statistically significant differences were noted in the incidence of adverse events among patients with chronic ulcers (moderate-quality evidence).

Innovation:

Our study suggests that HAM represents a promising and viable therapeutic strategy for the management of chronic wounds, including lower-extremity diabetic ulcers and venous ulcers.

Conclusion:

The application of HAM provides a safer and more effective therapeutic approach compared with conventional management alone for patients suffering from chronic refractory ulcers.