Clinical Trial

Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds

Recruiting
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Summary
This multicenter real-world study evaluates the efficacy and safety of a novel technique for rapid intraoperative construction of tissue-engineered skin using autologous epidermal stem cells (EpiSCs) for repairing difficult-to-heal wounds. Eligible patients are randomized to receive either: (1) the experimental intervention (rapidly constructed EpiSCs-loaded scaffold combined with split-thickness skin graft via one-step or two-step procedure), or (2) control intervention (acellular scaffold combined with split-thickness skin graft). The primary outcome is the complete wound healing rate at 4 weeks post-surgery. Secondary outcomes include wound recurrence, scar quality (VSS/POSAS), functional recovery (sweat test), mortality, amputation rate, and safety profile.
Trial Details
NCT Number NCT07562230
Lead Sponsor First Affiliated Hospital, Sun Yat-Sen University
Conditions Wounds and Injuries / Mortality
Enrollment 1,000 participants
Start Date 2026-01-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-01