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

NCT07562230 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

PROCEDURE

Rapid Tissue-Engineered Skin

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.

PROCEDURE

Traditional Composite Skin Graft

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.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-12-31
Completion
2030-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562230 on ClinicalTrials.gov