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 Type
OBSERVATIONAL
Enrollment
1,000
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.
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.
Time frame: 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.
Time frame: From surgery to complete healing, assessed up to 6 months
Wound Area Reduction Rate
Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
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