Rapidly constructed tissue-engineered skin to repair hard-to-heal wounds
Official title: Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study
Run by First Affiliated Hospital, Sun Yat-Sen University · NCT07562230 · Data updated 2026-11-12
This trial tries a fast, personalized skin graft made from your own epidermal stem cells to see if it heals hard-to-heal wounds faster and with fewer complications than a standard graft.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | December 1, 2030 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07562230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients of any age with a single 10–100 cm² acute or chronic wound requiring surgical repair whose wound bed is clean and infection-controlled and who can consent to the procedure and long-term follow-up.
✕Probably not a fit
Patients with severe immunosuppression, uncontrolled systemic infection, organ failure, malignant disease, allergy to scaffold or collagen materials, pregnant or lactating women, or those unable to comply with treatment or follow-up are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized real-world study comparing a rapidly constructed epidermal stem cell (EpiSC)-loaded scaffold combined with split-thickness skin graft (one-step or two-step) versus an acellular scaffold combined with split-thickness skin graft. Eligible patients with single-area wounds of 10–100 cm² (acute burns, traumatic defects, post-scar resection, diabetic foot ulcers, pressure injuries, or vascular ulcers) whose wound beds are prepared and infection-controlled will be randomized. The primary outcome is complete wound healing at 4 weeks post-surgery, with secondary outcomes including wound recurrence, scar quality (VSS/POSAS), functional recovery (sweat test), mortality, amputation rate, and safety. Safety monitoring will include adverse events related to the scaffold, infection, and organ/systemic complications.
Why it matters
Potential benefit: If successful, this approach could speed complete wound closure, reduce scarring, and lower rates of infection, amputation, or death for patients with difficult-to-heal wounds.
How similar studies have gone: Related tissue-engineered skin approaches using cultured autologous epidermal cells have shown promise in small studies, but rapid intraoperative construction with EpiSC-loaded scaffolds is a newer technique with limited large-scale evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Hu Zhicheng
- Email: huzhch5@mail.sysu.edu.cn
- Phone: 87755766-8265
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.