EpiSC-Enhanced Composite Grafts for Skin Reconstruction

NCT02070809 | Completed DMC

• 1 other identifier: 2013001
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound

Keywords

wound; tissue-engineered skin

Outcome Measures

Primary Outcomes (1)

• Scar Quality Assessed by the Vancouver Scar Scale (VSS)

  Scar quality was assessed using the Vancouver Scar Scale (VSS), which evaluates four domains: pigmentation, vascularity, pliability, and height. Each domain was scored independently by two experienced blinded clinicians, and the average scores were used for analysis. The total VSS score ranges from 0 to 13, with lower scores indicating better scar quality.

  6 months after treatment

Secondary Outcomes (1)

• Complete Wound Healing

  postsurgery week 2

Other Outcomes (1)

• recurrence rate

  3 months after treatment

Study Arms (2)

Cell Therapy

EXPERIMENTAL

Participants received acellular dermal matrix (ADM) and split-thickness skin grafting (STSG) with the addition of an intraoperatively prepared autologous epidermal stem cell (EpiSC)-enriched basal cell suspension. The cell suspension was applied to the wound bed and to the surface of the ADM before placement of the STSG.

Procedure: EpiSC-Enhanced Composite Grafting

Standard Treatment

ACTIVE COMPARATOR

Participants received acellular dermal matrix (ADM) followed by split-thickness skin grafting (STSG), without application of the EpiSC-enriched cell suspension.

Procedure: Standard Composite Grafting

Interventions

EpiSC-Enhanced Composite Grafting PROCEDURE

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.

Cell Therapy

Standard Composite Grafting PROCEDURE

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.

Standard Treatment

Eligibility Criteria

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

You may qualify if:

• Patients requiring skin grafting for full-thickness skin defects caused by burns, ulcers, scars, or other conditions.
• Wound area greater than 9 cm². Willing to participate in the clinical trial, provide written informed consent, and comply with follow-up requirements. For minors, consent was provided by a legal guardian.
• Mentally capable of understanding and following medical instructions.

You may not qualify if:

• Known allergy to trypsin or collagen. Acute systemic infection, uncontrolled severe disease, or serious organ dysfunction.
• Planned pregnancy during the study period or within 6 months after skin grafting.
• Malignant tumors, autoimmune diseases, or use of high-dose glucocorticoids, defined as ≥40 mg prednisone per day or an equivalent dose for ≥2 weeks.
• Positive bacterial culture indicating wound infection. Limb vascular neuropathy. Expected inability to survive during the study period. Participation in another clinical study within the previous 12 weeks.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jiayuan Zhu, doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, vice director of surgery

Study Record Dates

• First Submitted: February 22, 2014
• First Posted: February 25, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)