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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Epidermal Basal Cell Suspension | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From surgery to complete healing, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Area Reduction Rate | Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Proportion of participants experiencing local adverse reactions (infection, hematoma, seroma, graft necrosis, delayed healing, donor site complications, hypertrophic scarring) or systemic adverse reactions (fever, allergy). Rate of re-operation due to complications will also be recorded. | From enrollment to 6 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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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
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| 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. | 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. | 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. | Month 6 |