Wound HealingNCT07551284
Basement Membrane Regeneration for Wound Repair
An observational study of Wound Healing, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a cell sorting system) for wound repair in patients undergoing skin grafting, flap surgery… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Healing
- What is being tested?
- Autologous Epidermal Basal Cell Suspension
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: The study population will be recruited from patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture) at the burn units, plastic surgery departments, or wound repair departments of 10 participating tertiary hospitals across China, with Sun Yat-sen University First Affiliated Hospital serving as the lead center. Eligible participants are those requiring surgical wound repair who meet the inclusion criteria. Patients in the experimental group will receive autologous epidermal basal cell suspension combined with standard surgical procedures. Patients in the control group will receive standard surgical procedures alone (skin grafting, flap surgery, or primary suture without cell suspension). Group assignment is based on clinical practice and patient preference, not randomization. The study covers diverse wound types, including acute wounds (burns, trauma, post-excision defects) and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, et
Who may be able to join
- Patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture), including but not limited to: burn wounds, traumatic wounds, post-surgical excision defects (e.g., scars, pigmentation disorders, skin tumors), and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, radiation ulcers, neuropathic ulcers, burn residual wounds, etc.).
- Age (No age restriction). For minors under 18 years, informed consent must be provided by a parent or legal guardian.
- Stable vital signs and able to tolerate surgery as confirmed by routine examinations.
- Understand and willing to participate and able to provide signed informed consent.
Who cannot join
- Severe uncontrolled systemic disease or acute systemic infection, rapidly progressive or advanced disease, or severe organ dysfunction (heart, lung, brain, etc.).
- Psychiatric disorder.
- Presence of diseases (e.g., malignant tumor, autoimmune disease) or use of medications (e.g., high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect wound healing.
- HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
- Pregnancy or breastfeeding.
- Active infection or necrosis of the wound (unless controlled after debridement).
About this study
Official title: A Prospective, Multicenter, Real-World Observational Study of Autologous Basement Membrane Regeneration Technology (Epidermal Basal Cell Suspension Using Cell Sorting System) for Wound Repair in Patients Undergoing Skin Grafting, Flap Surgery, or Primary Suture
This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a cell sorting system) for wound repair in patients undergoing skin grafting, flap surgery, or primary suture. A total of 500 patients receiving the cell suspension therapy combined with standard surgical procedures will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients receiving standard surgical procedures alone (e.g., skin grafting, flap surgery, or suture without cell suspension). The primary outcomes include complete wound healing rate at 4 weeks (for grafted wounds) and time to complete wound closure (for sutured or flap-repaired wounds). Secondary outcomes include wound area reduction rate, recurrence rate, scar assessment (Vancouver Scar Scale), pain score (ASA), sweat function test, basement membrane integrity (histopathology with collagen IV and VII staining if clinically indicated), and safety. Patients will be followed for up to 6 months.
- Conditions
- Wound Healing
- Being tested
- Autologous Epidermal Basal Cell Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Epidermal Basal Cell SuspensionProcedure or surgery
A suspension of basal cells enriched from the patient's own split-thickness skin graft using a cell sorting system. The suspension contains epidermal basal cells and basement membrane components. It is applied to the wound bed or injected along suture lines to promote in situ basement membrane regeneration, enhance wound healing, and reduce scar formation.
| Study group | Role | What they receive |
|---|---|---|
| Basement Membrane Regeneration Group | Patients receiving autologous epidermal basal cell suspension (prepared using a cell sorting system from a split-thickness skin graft) combined with standard surgical procedures. The cell suspension is sprayed onto the wound bed before skin grafting or injected continuously at points along both sides of the suture line after flap surgery or tension-reducing suture to promote in situ basement membrane regeneration. Receives: Procedure: Autologous Epidermal Basal Cell Suspension | |
| Conventional Surgery Group | Patients receiving standard surgical procedures alone (skin grafting, flap surgery, or primary suture) without autologous epidermal basal cell suspension. Wound debridement, dressing changes, and postoperative care are identical to the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Healing Rate at 4 Weeks (for grafted wounds)
Proportion of skin graft recipient sites achieving complete epithelialization without drainage at 4 weeks post-surgery.
Measured: 4 weeks after surgery
Time to Complete Wound Healing (for sutured or flap-repaired wounds)
Number of days from surgery to complete wound closure (100% re-epithelialization or suture removal without dehiscence) for primarily sutured wounds or flap-repaired wounds.
Measured: From surgery to complete healing, assessed up to 6 months
Secondary outcomes (5)
Wound Area Reduction Rate
Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%.
Measured: 2 weeks after surgery
Recurrence Rate
Proportion of participants experiencing wound recurrence (re-ulceration at the same site or scar hyperplasia affecting function) within 6 months after complete healing.
Measured: 6 months after surgery
Scar Assessment
Scar quality is evaluated using the Vancouver Scar Scale (VSS), which assesses four parameters: vascularity, pigmentation, pliability, and height.
Scale specifications: The VSS is a 0-13 scale (0 = normal skin, 13 = worst possible scar), where higher scores indicate worse scar outcome.
Measured: Month 1, month 3, month 6
Pain Score
The ASA is a 0-10 scale, where higher scores indicate worse pain (0 = no pain, 10 = worst possible pain). Note: Please confirm if this interpretation aligns with your study's use of ASA.
Measured: Postoperative day 7, 14, month 1, 3, 6
Sweat Function Test
Assessment of sweat gland function recovery in the healed wound area using standardized sweat testing.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- 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
- NCT07551284
- Sponsor's protocol ID
- SYSU-BM-REGEN-2025-01
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Real-World Observational Study of Autologous Basement Membrane Regeneration Technology (Epidermal Basal Cell Suspension Using Cell Sorting System) for Wound Repair in Patients Undergoing Skin Grafting, Flap Surgery, or Primary Suture
- ClinicalTrials.gov ID
- NCT07551284
- Acronym / sponsor ID
- SYSU-BM-REGEN-2025-01
- Conditions
- Wound Healing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Apr 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 study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a cell sorting system) for wound repair in patients undergoing skin grafting, flap surgery, or primary suture. A total of 500 patients receiving the cell suspension therapy combined with standard surgical procedures will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients receiving standard surgical procedures alone (e.g., skin grafting, flap surgery, or suture without cell suspension). The primary outcomes include complete wound healing rate at 4 weeks (for grafted wounds) and time to complete wound closure (for sutured or flap-repaired wounds). Secondary outcomes include wound area reduction rate, recurrence rate, scar assessment (Vancouver Scar Scale), pain score (ASA), sweat function test, basement membrane integrity (histopathology with collagen IV and VII staining if clinically indicated), and safety. Patients will be followed for up to 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basement Membrane Regeneration Group | – | Procedure: Autologous Epidermal Basal Cell SuspensionPatients receiving autologous epidermal basal cell suspension (prepared using a cell sorting system from a split-thickness skin graft) combined with standard surgical procedures. The cell suspension is sprayed onto the wound bed before skin grafting or injected continuously at points along both sides of the suture line after flap surgery or tension-reducing suture to promote in situ basement membrane regeneration. |
| Conventional Surgery Group | – | –Patients receiving standard surgical procedures alone (skin grafting, flap surgery, or primary suture) without autologous epidermal basal cell suspension. Wound debridement, dressing changes, and postoperative care are identical to the experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be recruited from patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture) at the burn units, plastic surgery departments, or wound repair departments of 10 participating tertiary hospitals across China, with Sun Yat-sen University First Affiliated Hospital serving as the lead center. Eligible participants are those requiring surgical wound repair who meet the inclusion criteria. Patients in the experimental group will receive autologous epidermal basal cell suspension combined with standard surgical procedures. Patients in the control group will receive standard surgical procedures alone (skin grafting, flap surgery, or primary suture without cell suspension). Group assignment is based on clinical practice and patient preference, not randomization. The study covers diverse wound types, including acute wounds (burns, trauma, post-excision defects) and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, et
Key inclusion criteria (4 listed)
- Patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture), including but not limited to: burn wounds, traumatic wounds, post-surgical excision defects (e.g., scars, pigmentation disorders, skin tumors), and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, radiation ulcers, neuropathic ulcers, burn residual wounds, etc.).
- Age (No age restriction). For minors under 18 years, informed consent must be provided by a parent or legal guardian.
- Stable vital signs and able to tolerate surgery as confirmed by routine examinations.
- Understand and willing to participate and able to provide signed informed consent.
Key exclusion criteria (6 listed)
- Severe uncontrolled systemic disease or acute systemic infection, rapidly progressive or advanced disease, or severe organ dysfunction (heart, lung, brain, etc.).
- Psychiatric disorder.
- Presence of diseases (e.g., malignant tumor, autoimmune disease) or use of medications (e.g., high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect wound healing.
- HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Autologous Epidermal Basal Cell SuspensionA suspension of basal cells enriched from the patient's own split-thickness skin graft using a cell sorting system. The suspension contains epidermal basal cells and basement membrane components. It is applied to the wound bed or injected along suture lines to promote in situ basement membrane regeneration, enhance wound healing, and reduce scar formation. | Procedure or surgery | Basement Membrane Regeneration Group |
Primary outcome
Complete Wound Healing Rate at 4 Weeks (for grafted wounds)
Time frame: 4 weeks after surgery
Proportion of skin graft recipient sites achieving complete epithelialization without drainage at 4 weeks post-surgery.
Time to Complete Wound Healing (for sutured or flap-repaired wounds)
Time frame: From surgery to complete healing, assessed up to 6 months
Number of days from surgery to complete wound closure (100% re-epithelialization or suture removal without dehiscence) for primarily sutured wounds or flap-repaired wounds.
5 secondary outcomes
Wound Area Reduction Rate
Time frame: 2 weeks after surgery
Recurrence Rate
Time frame: 6 months after surgery
Scar Assessment
Time frame: Month 1, month 3, month 6
Pain Score
Time frame: Postoperative day 7, 14, month 1, 3, 6
Sweat Function Test
Time frame: Month 6
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 29 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing, run by First Affiliated Hospital, Sun Yat-Sen University.
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 6 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Complete Wound Healing Rate at 4 Weeks (for grafted wounds) (time frame: 4 weeks after surgery). The study lists 2 primary outcomes in all. 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 29 Apr 2026.