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Cell Suspension With Biologic Dressing for Burn Wounds
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
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 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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
386
Start Date
2026-05-01
Completion Date
2029-12-31
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
Autologous Epidermal Cell Suspension
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.