Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds

NCT07562230 | Recruiting

• 1 other identifier: 2026P-ZD025
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries / Mortality

Outcome Measures

Primary Outcomes (1)

• Complete Wound Healing Rate

  The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）

  At 4 weeks post-surgery

Secondary Outcomes (7)

• Wound Recurrence Rate

  3, 6, 12 months post-surgery

• Scar Quality Assessment

  4 weeks, 3, 6, 12 months post-surgery

• Functional Recovery

  6, 12 months post-surgery

• Mortality Rate

  3, 6, 12 months post-surgery

• Amputation Rate

  3, 6, 12 months post-surgery

Study Arms (2)

Rapid Tissue-Engineered Skin Group

EXPERIMENTAL

Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）

Procedure: Rapid Tissue-Engineered Skin

Traditional Composite Skin Graft Group

ACTIVE COMPARATOR

Procedure: Traditional Composite Skin Graft

Interventions

Rapid Tissue-Engineered Skin PROCEDURE

Autologous split-thickness skin (0.15-0.2 mm) is harvested from the donor site at a donor-to-wound area ratio of 1:20-30. The harvested skin is processed using a specialized cell sorter to isolate autologous epidermal stem cells (EpiSCs) with \>93% viability within 30 minutes. The cell suspension is adjusted to a concentration of ≥1×10⁶ cells/mL and loaded onto a tissue-engineered scaffold via spraying or immersion (3-5 minutes). The cell-seeded scaffold is then applied to the wound bed. Depending on wound condition: (1) One-step procedure: scaffold and a split-thickness skin graft (0.15-0.2 mm) are applied simultaneously; (2) Two-step procedure: scaffold is implanted first, followed by split-thickness skin graft at 14±3 days post-primary surgery. Negative pressure wound therapy (-100 to -125 mmHg) is applied as needed.

Rapid Tissue-Engineered Skin Group

Traditional Composite Skin Graft PROCEDURE

The same tissue-engineered scaffold (without cell loading) is used. Autologous split-thickness skin graft (0.15-0.2 mm thickness) is harvested. The acellular scaffold is applied to the debrided wound bed followed by coverage with the split-thickness skin graft. The surgical procedure, postoperative wound care, negative pressure wound therapy (-100 to -125 mmHg when indicated), and follow-up protocol are identical to those in the experimental arm. This comparator represents the current standard of care for composite skin grafting in the participating centers.

Traditional Composite Skin Graft Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Hu Zhicheng

CONTACT

87755766-8265; huzhch5@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 1, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)