Wound Healing
Conditions
Brief 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, 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.
Interventions
PROCEDUREAutologous Epidermal Basal Cell Suspension
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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing Rate at 4 Weeks (for grafted wounds) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area Reduction Rate | 2 weeks after surgery | Percentage reduction in wound area calculated as (baseline area - current area) / baseline area × 100%. |
| Recurrence Rate | 6 months after surgery | Proportion of participants experiencing wound recurrence (re-ulceration at the same site or scar hyperplasia affecting function) within 6 months after complete healing. |
| Scar Assessment | Month 1, month 3, month 6 | 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. |
| Pain Score | Postoperative day 7, 14, month 1, 3, 6 | 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. |
| Sweat Function Test | Month 6 | Assessment of sweat gland function recovery in the healed wound area using standardized sweat testing. |
Outcome results
None listed