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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Epidermal Cell Suspension | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Rate at 4 Weeks | Proportion of wounds achieving complete epithelialization without drainage at 4 weeks post-treatment. | 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). | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Proportion of participants experiencing local adverse reactions (erythema, edema, exudation, infection, rejection signs, rash, itching, allergy) or systemic adverse reactions (fever, systemic infection). | From enrollment to 6 months after treatment completion |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Month 3, month 6 |
| Pigmentation Assessment | Month 3, month 6 | 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. | 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. | Month 6 |