Efficacy of a dual-layer pre-hydrated amniotic membrane allograft in the treatment of hard-to-heal wounds

Objective: Hard-to-heal wounds refractory to standard of care (SoC) apy pose a major clinical and economic burden on healthcare ems. A dual-layer hydrated human amniotic membrane (HAMA) graft, pre-hydrated with saline, is an emerging advanced therapy complex hard-to-heal wounds. The aim of this study was to uate the real-world effectiveness of Membrane Wrap Hydro Lab Holdings, Inc., US) in achieving complete closure and relative centage area reduction (PAR) across hard-to-heal diabetic foot rs (DFUs), venous leg ulcers (VLUs), pressure injuries (PIs) and n wounds. Method: This was a retrospective multicentre analysis of patients ted from November 2024 to July 2025 after ≥30 days of optimised C with <50% healing. Weekly applications of HAMA were ormed in outpatient clinics, nursing homes or home settings. The mary endpoint was complete wound closure (99.99–100% pithelialisation). Secondary endpoints were: PAR (paired samples st); applications to closure; and time-to-healing (Kaplan–Meier). Results: The cohort included 80 patients (83 wounds). Complete closure occurred in 46/83 (55.4%) wounds with a median six applications (mean: 6.54±3.22). Closure rates were: 53.3% (DFUs); 50.0% (VLUs); 47.1% (PIs); and 59.6% (open wounds). Mean PAR was 84.3%, with significant area reduction from baseline (p<0.001; Cohen's d=0.79). Large effect sizes were observed across aetiologies (d=1.01–1.84). Median time-to-healing was 42 days (range: 7–110). Conclusion: Membrane Wrap Hydro achieved clinically meaningful closure and substantial PAR across diverse refractory hard-to-heal wounds, with outcomes in PIs and open wounds comparable or superior to DFUs and VLUs. These findings support the role of HAMA as a versatile advanced therapy in multimodal hard-to-heal wound management.