Rapidly constructed tissue-engineered skin to repair hard-to-heal wounds
Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07562230 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.