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COMPLETED
NCT02070809
NA

EpiSC-Enhanced Composite Grafts for Skin Reconstruction

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This randomized controlled trial evaluated a single-stage treatment for full-thickness skin defects using an autologous epidermal stem cell (EpiSC)-enriched cell suspension prepared during surgery. Participants received either standard treatment with an acellular dermal matrix and a split-thickness skin graft, or the same treatment with the addition of the EpiSC-enriched cell suspension. The study was designed to determine whether adding the cell suspension could improve wound healing and scar quality while maintaining treatment safety. Wound healing, wound recurrence, scar quality, and adverse events were assessed during follow-up.

Official title: Bio-Inspired Skin Reconstruction Using Intraoperative Autologous Epidermal Stem Cell-Enhanced Composite Grafts: A Randomized Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

232

Start Date

2013-12

Completion Date

2024-12

Last Updated

2026-09-02

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

EpiSC-Enhanced Composite Grafting

Participants received acellular dermal matrix (ADM) and split-thickness skin grafting (STSG) combined with an intraoperatively prepared autologous epidermal stem cell (EpiSC)-enriched basal cell suspension. The cell suspension was first applied to the wound bed, followed by placement of the ADM. A second application of the cell suspension was made to the ADM surface, and the STSG was then overlaid.

PROCEDURE

Standard Composite Grafting

Participants received standard composite grafting consisting of acellular dermal matrix (ADM) applied to the prepared wound bed and immediately covered with a split-thickness skin graft (STSG), without application of the EpiSC-enriched cell suspension.

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China