WoundNCT02070809
EpiSC-Enhanced Composite Grafts for Skin Reconstruction
A study testing EpiSC-Enhanced Composite Grafting and Standard Composite Grafting in people with Wound, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound
- What is being tested?
- EpiSC-Enhanced Composite Grafting and Standard Composite Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound
- Being tested
- EpiSC-Enhanced Composite Grafting, Standard Composite Grafting
- Keywords
- wound, tissue-engineered skin
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiSC-Enhanced Composite GraftingProcedure or surgery
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.
Standard Composite GraftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard Composite Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after treatment
Secondary outcomes (1)
Complete Wound Healing
Complete wound healing was defined as complete epithelialization of the target wound with no signs of infection or inflammation.
Measured: postsurgery week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Jiayuan, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jiayuan Zhu, doctor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070809
- Sponsor's protocol ID
- 2013001
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2014
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-Inspired Skin Reconstruction Using Intraoperative Autologous Epidermal Stem Cell-Enhanced Composite Grafts: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02070809
- Acronym / sponsor ID
- 2013001
- Conditions
- Wound
- Keywords
- wound, tissue-engineered skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell Therapy | Experimental | Procedure: EpiSC-Enhanced Composite GraftingParticipants 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. |
| Standard Treatment | Active comparator | Procedure: Standard Composite GraftingParticipants received acellular dermal matrix (ADM) followed by split-thickness skin grafting (STSG), without application of the EpiSC-enriched cell suspension. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiSC-Enhanced Composite GraftingParticipants 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 or surgery | Cell Therapy |
| Standard Composite GraftingParticipants 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. | Procedure or surgery | Standard Treatment |
Primary outcome
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.
1 secondary outcome
Complete Wound Healing
Time frame: postsurgery week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayuan Zhu, doctor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiSC-Enhanced Composite Grafting and Standard Composite Grafting in people with Wound, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Quality Assessed by the Vancouver Scar Scale (VSS) (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.