Cell Suspension With Biologic Dressing for Burn Wounds

Starting soon

Conditions studied: Wound Healing

In brief

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.

Key facts

Study ID

NCT07555418

Run by

First Affiliated Hospital, Sun Yat-Sen University

People needed

386

Starts

2026-05-01

Expected to finish

2029-12-31

Last updated by the study team

2026-04-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with second-degree burn wounds requiring surgical dermabrasion or debridement and wound repair.
• 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 debridement and surgical procedures as confirmed by routine examinations.
• Understand and willing to participate and able to provide signed informed consent.

You may not qualify if…

• Severe uncontrolled systemic disease or acute systemic infection, or severe organ dysfunction (heart, lung, brain, etc.).
• Psychiatric disorder that prevents compliance with treatment or follow-up.
• Known allergy to porcine-derived materials or any component of the cell suspension preparation reagents.
• Presence of diseases (e.g., autoimmune disease) or use of medications (e.g., high-dose immunosuppressants or corticosteroids) that may significantly affect wound healing.
• HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.

Full record on ClinicalTrials.gov

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