EpiSC-Enhanced Composite Grafts for Skin Reconstruction

August 31, 2026 updated by: Zhu Jiayuan, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Full-thickness skin defects caused by burns, ulcers, scars, trauma, or other conditions can result in functional impairment, visible scarring, and substantial reconstructive challenges. Conventional split-thickness skin grafting is widely used for wound closure, but graft contraction, delayed vascularization, donor-site morbidity, and suboptimal scar quality may limit clinical outcomes.

Tissue-engineered skin combines a supporting matrix with viable cells to more closely reproduce the structure and function of native skin. Epidermal stem cells (EpiSCs) are of particular interest because of their potential roles in epithelial regeneration, angiogenesis, immune modulation, and extracellular matrix remodeling. However, conventional cell-based approaches may require prolonged in vitro culture and specialized facilities, limiting their routine clinical use.

In this study, the investigators used a standardized intraoperative cell isolation system to prepare an autologous EpiSC-enriched basal cell suspension from residual fragments of split-thickness skin graft obtained from the participant during surgery. The cell suspension was prepared and applied immediately without prolonged in vitro expansion.

In the standard-treatment group, the prepared wound bed was covered with an acellular dermal matrix followed by a split-thickness skin graft. In the cell-therapy group, the EpiSC-enriched suspension was first applied to the wound bed, followed by placement of the acellular dermal matrix. A second application of the cell suspension was then made to the surface of the matrix before the split-thickness skin graft was placed. Postoperative wound care was performed using the same general protocol in both groups.

The study was designed to evaluate whether adding an intraoperatively prepared autologous EpiSC-enriched cell suspension to conventional composite grafting could improve the quality of full-thickness wound repair.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cell Therapy
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
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.
Active Comparator: Standard Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scar Quality Assessed by the Vancouver Scar Scale (VSS)
Time Frame: 6 months after treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Wound Healing
Time Frame: postsurgery week 2
Complete wound healing was defined as complete epithelialization of the target wound with no signs of infection or inflammation.
postsurgery week 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: 3 months after treatment
Wound recurrence was defined as reopening or breakdown of the previously healed target wound.
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital, Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiayuan Zhu, doctor, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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