Wounds and Injuries / MortalityNCT07562230
Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds
A study testing Rapid Tissue-Engineered Skin and Traditional Composite Skin Graft in people with Wounds and Injuries / Mortality, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries / Mortality
- What is being tested?
- Rapid Tissue-Engineered Skin and Traditional Composite Skin Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All-age population
- Wounds requiring surgical repair （single area 10-100 cm²）： acute wounds （burns, traumatic defects, post-scar resection） OR chronic wounds （diabetic foot ulcers, pressure injuries, vascular ulcers）
- Completed wound bed preparation （no necrotic tissue, infection controlled）
- Signed informed consent and agreement to use tissue-engineered materials and long-term follow-up
Who cannot join
- History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials
- Severe immunosuppression （HIV/AIDS, long-term immunosuppressant use）
- Malignant tumors, uncontrolled systemic infection （CRP > 50 mg/L）， or organ failure （Child-Pugh Class C）
- Mental illness preventing compliance with treatment or follow-up
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital of Sun Yat-sen University, 87755766-8265, huzhch5@mail.sysu.edu.cn
About this study
Official title: Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study
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.
- Conditions
- Wounds and Injuries / Mortality
- Being tested
- Rapid Tissue-Engineered Skin, Traditional Composite Skin Graft
- 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.
Rapid Tissue-Engineered SkinProcedure or surgery
Autologous split-thickness skin (0.15-0.2 mm) is harvested from the donor site at a donor-to-wound area ratio of 1:20-30. The harvested skin is processed using a specialized cell sorter to isolate autologous epidermal stem cells (EpiSCs) with >93% viability within 30 minutes. The cell suspension is adjusted to a concentration of ≥1×10⁶ cells/mL and loaded onto a tissue-engineered scaffold via spraying or immersion (3-5 minutes). The cell-seeded scaffold is then applied to the wound bed. Depending on wound condition: (1) One-step procedure: scaffold and a split-thickness skin graft (0.15-0.2 mm) are applied simultaneously; (2) Two-step procedure: scaffold is implanted first, followed by split-thickness skin graft at 14±3 days post-primary surgery. Negative pressure wound therapy (-100 to -125 mmHg) is applied as needed.
Traditional Composite Skin GraftProcedure or surgery
The same tissue-engineered scaffold (without cell loading) is used. Autologous split-thickness skin graft (0.15-0.2 mm thickness) is harvested. The acellular scaffold is applied to the debrided wound bed followed by coverage with the split-thickness skin graft. The surgical procedure, postoperative wound care, negative pressure wound therapy (-100 to -125 mmHg when indicated), and follow-up protocol are identical to those in the experimental arm. This comparator represents the current standard of care for composite skin grafting in the participating centers.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Tissue-Engineered Skin Group | Experimental | Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure） Receives: Procedure: Rapid Tissue-Engineered Skin |
| Traditional Composite Skin Graft Group | Active comparator | Not described Receives: Procedure: Traditional Composite Skin Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Healing Rate
The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）
Measured: At 4 weeks post-surgery
Secondary outcomes (7)
Wound Recurrence Rate
Incidence of wound recurrence at the healed site
Measured: 3, 6, 12 months post-surgery
Scar Quality Assessment
Scar quality is assessed using the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS) at 4 weeks, 3, 6, and 12 months post-surgery. The VSS total score ranges from 0 to 13, with higher scores indicating worse scar outcome (assessing vascularity, pigmentation, pliability, and height). The POSAS includes two separate subscales: the Observer Scale (6 items, each scored 1 to 10, total range 6-60) and the Patient Scale (6 items, each scored 1 to 10, total range 6-60). For both POSAS subscales, higher scores represent worse scar outcome.
Measured: 4 weeks, 3, 6, 12 months post-surgery
Functional Recovery
Sweat test for assessment of sweat gland regeneration
Measured: 6, 12 months post-surgery
Mortality Rate
All-cause mortality
Measured: 3, 6, 12 months post-surgery
Amputation Rate
Incidence of amputation （for chronic wound patients）
Measured: 3, 6, 12 months post-surgery
Healing Trajectory
Wound healing rate at week 1, 2, 3; and time to complete healing
Measured: 1, 2, 3 weeks post-surgery
Safety Outcome
Safety outcome is the incidence of postoperative complications (including infection, hematoma, and graft failure), adverse events, and serious adverse events, assessed from the day of surgery through study completion, an average of 12 months.
Measured: From day of surgery through 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and Injuries / MortalityStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Zhicheng, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562230
- Sponsor's protocol ID
- 2026P-ZD025
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT07562230
- Acronym / sponsor ID
- 2026P-ZD025
- Conditions
- Wounds and Injuries / Mortality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 1 May 2026 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Tissue-Engineered Skin Group | Experimental | Procedure: Rapid Tissue-Engineered SkinRapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure） |
| Traditional Composite Skin Graft Group | Active comparator | Procedure: Traditional Composite Skin Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All-age population
- Wounds requiring surgical repair （single area 10-100 cm²）： acute wounds （burns, traumatic defects, post-scar resection） OR chronic wounds （diabetic foot ulcers, pressure injuries, vascular ulcers）
- Completed wound bed preparation （no necrotic tissue, infection controlled）
- Signed informed consent and agreement to use tissue-engineered materials and long-term follow-up
Key exclusion criteria (5 listed)
- History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials
- Severe immunosuppression （HIV/AIDS, long-term immunosuppressant use）
- Malignant tumors, uncontrolled systemic infection （CRP > 50 mg/L）， or organ failure （Child-Pugh Class C）
- Mental illness preventing compliance with treatment or follow-up
- Pregnant or lactating women
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 |
|---|---|---|
| Rapid Tissue-Engineered SkinAutologous split-thickness skin (0.15-0.2 mm) is harvested from the donor site at a donor-to-wound area ratio of 1:20-30. The harvested skin is processed using a specialized cell sorter to isolate autologous epidermal stem cells (EpiSCs) with >93% viability within 30 minutes. The cell suspension is adjusted to a concentration of ≥1×10⁶ cells/mL and loaded onto a tissue-engineered scaffold via spraying or immersion (3-5 minutes). The cell-seeded scaffold is then applied to the wound bed. Depending on wound condition: (1) One-step procedure: scaffold and a split-thickness skin graft (0.15-0.2 mm) are applied simultaneously; (2) Two-step procedure: scaffold is implanted first, followed by split-thickness skin graft at 14±3 days post-primary surgery. Negative pressure wound therapy (-100 to -125 mmHg) is applied as needed. | Procedure or surgery | Rapid Tissue-Engineered Skin Group |
| Traditional Composite Skin GraftThe same tissue-engineered scaffold (without cell loading) is used. Autologous split-thickness skin graft (0.15-0.2 mm thickness) is harvested. The acellular scaffold is applied to the debrided wound bed followed by coverage with the split-thickness skin graft. The surgical procedure, postoperative wound care, negative pressure wound therapy (-100 to -125 mmHg when indicated), and follow-up protocol are identical to those in the experimental arm. This comparator represents the current standard of care for composite skin grafting in the participating centers. | Procedure or surgery | Traditional Composite Skin Graft Group |
Primary outcome
Complete Wound Healing Rate
Time frame: At 4 weeks post-surgery
The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）
7 secondary outcomes
Wound Recurrence Rate
Time frame: 3, 6, 12 months post-surgery
Scar Quality Assessment
Time frame: 4 weeks, 3, 6, 12 months post-surgery
Functional Recovery
Time frame: 6, 12 months post-surgery
Mortality Rate
Time frame: 3, 6, 12 months post-surgery
Amputation Rate
Time frame: 3, 6, 12 months post-surgery
Healing Trajectory
Time frame: 1, 2, 3 weeks post-surgery
Safety Outcome
Time frame: From day of surgery through 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Tissue-Engineered Skin and Traditional Composite Skin Graft in people with Wounds and Injuries / Mortality, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hu Zhicheng (87755766-8265, huzhch5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Healing Rate (time frame: At 4 weeks post-surgery). 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 1 May 2026.