Overview
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.
Eligibility
Inclusion Criteria:
- All-age population
Wounds requiring surgical repair （single area 10-100 cm²）： acute wounds （burns, traumatic defects, post-scar resection） OR chronic wounds （diabetic foot ulcers, pressure injuries, vascular ulcers）
Completed wound bed preparation （no necrotic tissue, infection controlled）
Signed informed consent and agreement to use tissue-engineered materials and long-term follow-up
Exclusion Criteria:
- History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials
Severe immunosuppression （HIV/AIDS, long-term immunosuppressant use）
Malignant tumors, uncontrolled systemic infection （CRP \> 50 mg/L）， or organ failure （Child-Pugh Class C）
Mental illness preventing compliance with treatment or follow-up
Pregnant or lactating women
