NCT07562230 Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds
| NCT ID | NCT07562230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Wounds and Injuries / Mortality |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2026-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07562230 clinical trial?
This trial is open to participants of all sexes, studying Wounds and Injuries / Mortality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07562230 currently recruiting?
Yes, NCT07562230 is actively recruiting participants. Contact the research team at huzhch5@mail.sysu.edu.cn for enrollment information.
Where is the NCT07562230 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07562230 clinical trial?
NCT07562230 is sponsored by First Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 1,000 participants.