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

Official title

Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study

Overview

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.

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. Dependi
• 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 o

Primary outcome measures

• Complete Wound Healing Rate [Time frame: At 4 weeks post-surgery]

Secondary outcome measures (7)

• Wound Recurrence Rate [Time frame: 3, 6, 12 months post-surgery]
• Scar Quality Assessment [Time frame: 4 weeks, 3, 6, 12 months post-surgery]
• Functional Recovery [Time frame: 6, 12 months post-surgery]
• Mortality Rate [Time frame: 3, 6, 12 months post-surgery]
• Amputation Rate [Time frame: 3, 6, 12 months post-surgery]
• Healing Trajectory [Time frame: 1, 2, 3 weeks post-surgery]
• Safety Outcome [Time frame: From day of surgery through 12 months post-surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07562230 · 2026P-ZD025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗