Actively Recruiting
Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-05-01
1000
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of all ages
- Wounds requiring surgical repair of single area 10-100 cm², including acute wounds (burns, traumatic defects, post-scar resection) or chronic wounds (diabetic foot ulcers, pressure injuries, vascular ulcers)
- Completed wound bed preparation with no necrotic tissue and controlled infection
- Signed informed consent and agreement to use tissue-engineered materials and participate in long-term follow-up
You will not qualify if you...
- History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials
- Severe immunosuppression such as HIV/AIDS or 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
H
Hu Zhicheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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