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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

All-age population

Disqualifiers

History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials

Trial design

Treatments tested in this trial

  • Rapid Tissue-Engineered Skin
  • Traditional Composite Skin Graft

Treatment groups

1,000 Participants
are divided into 2 treatment groups