Wound HealingNCT07555418
Cell Suspension With Biologic Dressing for Burn Wounds
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 a combined therapy-autologous epidermal cell suspension followed by biological dressing (porcine xenograft) coverage-for wound repair after dermabrasion or surgical debridement in patients with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Healing
- What is being tested?
- Autologous Epidermal Cell Suspension
- Type of treatment
- Surgery or procedure
- How many people
- 386 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 second-degree burn wounds requiring dermabrasion or surgical debridement at the burn units or wound repair departments of multiple tertiary hospitals across China, with Sun Yat-sen University First Affiliated Hospital serving as the lead center. Eligible participants are those requiring surgical debridement and wound repair who meet the inclusion criteria. Patients in the combined therapy group will receive autologous epidermal cell suspension followed by porcine xenograft coverage. Patients in the conventional treatment group will receive standard care without cell suspension (e.g., xenograft alone, autologous skin grafting, or standard dressing changes). Group assignment is based on clinical practice and patient preference, not randomization. The study aims to reflect real-world clinical practice across diverse burn care settings.
Who may be able to join
- Patients with second-degree burn wounds requiring surgical dermabrasion or debridement and wound repair.
- 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 debridement and surgical procedures 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, or severe organ dysfunction (heart, lung, brain, etc.).
- Psychiatric disorder that prevents compliance with treatment or follow-up.
- Known allergy to porcine-derived materials or any component of the cell suspension preparation reagents.
- Presence of diseases (e.g., autoimmune disease) or use of medications (e.g., high-dose immunosuppressants or corticosteroids) that may significantly affect wound healing.
- HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
About this study
Official title: A Prospective, Multicenter, Real-World Observational Study of Autologous Epidermal Cell Suspension Combined With Biological Dressing for Wound Repair After Dermabrasion or Surgical Debridement in Patients With Second-Degree Burns
This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of a combined therapy-autologous epidermal cell suspension followed by biological dressing (porcine xenograft) coverage-for wound repair after dermabrasion or surgical debridement in patients with second-degree burns. A total of 193 patients receiving the combined therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 193 matched patients who received conventional treatment alone (e.g., xenograft alone, autologous skin grafting, or standard dressing changes). The primary outcomes include wound healing rate at 4 weeks and time to complete wound closure. Secondary outcomes include scar assessment, pigmentation, functional recovery, quality of life, and safety. Patients will be followed for up to 6 months.
- Conditions
- Wound Healing
- Being tested
- Autologous Epidermal Cell Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Epidermal Cell SuspensionProcedure or surgery
A suspension of viable epidermal cells (including basal cells, epidermal stem cells, keratinocytes, melanocytes, and fibroblasts) isolated from a small sample of the patient's own skin. The suspension is sprayed onto the debrided wound bed to promote re-epithelialization.
| Study group | Role | What they receive |
|---|---|---|
| Combined Therapy Group | Patients receiving autologous epidermal cell suspension sprayed onto the wound bed immediately after dermabrasion or surgical debridement, followed by coverage with porcine xenograft as a temporary biological dressing. Receives: Procedure: Autologous Epidermal Cell Suspension | |
| Conventional Treatment Group | Patients receiving conventional treatment after dermabrasion or surgical debridement without autologous epidermal cell suspension, including but not limited to: porcine xenograft alone, autologous skin grafting, or standard dressing changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Rate at 4 Weeks
Proportion of wounds achieving complete epithelialization without drainage at 4 weeks post-treatment.
Measured: 4 weeks after treatment
Time to Complete Wound Healing
Time to complete wound healing is defined as the number of days from initial treatment to complete wound closure (100% re-epithelialization).
Measured: Up to 6 months
Secondary outcomes (4)
Scar Assessment
Scar quality is evaluated using the Vancouver Scar Scale (VSS) or the Patient and Observer Scar Assessment Scale (POSAS), per site standard or investigator discretion.
Scale specifications:
VSS: Scores range from 0 to 13, where higher scores indicate worse scar outcome (0 = normal skin, 13 = worst possible scar).
POSAS: Consists of Observer Scale (6 items: vascularity, pigmentation, thickness, relief, pliability, surface area) and Patient Scale (6 items: pain, itching, color, stiffness, thickness, irregularity). Each item is scored 1-10 (1 = normal skin/no complaint, 10 = worst imaginable). Total score ranges from 6 to 60. Higher scores indicate worse scar outcome.
Measured: Month 3, month 6
Pigmentation Assessment
Month 3, month 6
Measured: Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.
Functional Recovery
Assessment of functional status of the healed area, including range of motion for wounds over joints.
Measured: Month 6
Quality of Life
Quality of life is assessed using a validated questionnaire, the Burn Specific Health Scale-Brief (BSHS-B).
Scale specifications: The BSHS-B consists of multiple domains (e.g., physical function, psychological function, social function, general health, and work). Each item is scored on a 0-4 scale (0 = extreme problem, 4 = no problem). Domain and total scores are transformed to a 0-100 scale, where higher scores indicate better quality of life.
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 posted29 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
- 386 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
- NCT07555418
- Sponsor's protocol ID
- SYSU-CELL-SKIN-2026-01
- 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 Epidermal Cell Suspension Combined With Biological Dressing for Wound Repair After Dermabrasion or Surgical Debridement in Patients With Second-Degree Burns
- ClinicalTrials.gov ID
- NCT07555418
- Acronym / sponsor ID
- SYSU-CELL-SKIN-2026-01
- Conditions
- Wound Healing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 386 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
- 29 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 a combined therapy-autologous epidermal cell suspension followed by biological dressing (porcine xenograft) coverage-for wound repair after dermabrasion or surgical debridement in patients with second-degree burns. A total of 193 patients receiving the combined therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 193 matched patients who received conventional treatment alone (e.g., xenograft alone, autologous skin grafting, or standard dressing changes). The primary outcomes include wound healing rate at 4 weeks and time to complete wound closure. Secondary outcomes include scar assessment, pigmentation, functional recovery, quality of life, 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 |
|---|---|---|
| Combined Therapy Group | – | Procedure: Autologous Epidermal Cell SuspensionPatients receiving autologous epidermal cell suspension sprayed onto the wound bed immediately after dermabrasion or surgical debridement, followed by coverage with porcine xenograft as a temporary biological dressing. |
| Conventional Treatment Group | – | –Patients receiving conventional treatment after dermabrasion or surgical debridement without autologous epidermal cell suspension, including but not limited to: porcine xenograft alone, autologous skin grafting, or standard dressing changes. |
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 second-degree burn wounds requiring dermabrasion or surgical debridement at the burn units or wound repair departments of multiple tertiary hospitals across China, with Sun Yat-sen University First Affiliated Hospital serving as the lead center. Eligible participants are those requiring surgical debridement and wound repair who meet the inclusion criteria. Patients in the combined therapy group will receive autologous epidermal cell suspension followed by porcine xenograft coverage. Patients in the conventional treatment group will receive standard care without cell suspension (e.g., xenograft alone, autologous skin grafting, or standard dressing changes). Group assignment is based on clinical practice and patient preference, not randomization. The study aims to reflect real-world clinical practice across diverse burn care settings.
Key inclusion criteria (4 listed)
- Patients with second-degree burn wounds requiring surgical dermabrasion or debridement and wound repair.
- 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 debridement and surgical procedures as confirmed by routine examinations.
- Understand and willing to participate and able to provide signed informed consent.
Key exclusion criteria (5 listed)
- Severe uncontrolled systemic disease or acute systemic infection, or severe organ dysfunction (heart, lung, brain, etc.).
- Psychiatric disorder that prevents compliance with treatment or follow-up.
- Known allergy to porcine-derived materials or any component of the cell suspension preparation reagents.
- Presence of diseases (e.g., autoimmune disease) or use of medications (e.g., high-dose immunosuppressants or corticosteroids) that may significantly affect wound healing.
- HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
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 Cell SuspensionA suspension of viable epidermal cells (including basal cells, epidermal stem cells, keratinocytes, melanocytes, and fibroblasts) isolated from a small sample of the patient's own skin. The suspension is sprayed onto the debrided wound bed to promote re-epithelialization. | Procedure or surgery | Combined Therapy Group |
Primary outcome
Wound Healing Rate at 4 Weeks
Time frame: 4 weeks after treatment
Proportion of wounds achieving complete epithelialization without drainage at 4 weeks post-treatment.
Time to Complete Wound Healing
Time frame: Up to 6 months
Time to complete wound healing is defined as the number of days from initial treatment to complete wound closure (100% re-epithelialization).
4 secondary outcomes
Scar Assessment
Time frame: Month 3, month 6
Pigmentation Assessment
Time frame: Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.
Functional Recovery
Time frame: Month 6
Quality of Life
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 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: 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?
Wound Healing Rate at 4 Weeks (time frame: 4 weeks after treatment). 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.