Cell Suspension With Biologic Dressing for Burn Wounds

NCT07555418 | Not Yet Recruiting

• 1 other identifier: SYSU-CELL-SKIN-2026-01
• Study Type: observational
• Target: 386
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (2)

• Wound Healing Rate at 4 Weeks

  Proportion of wounds achieving complete epithelialization without drainage at 4 weeks post-treatment.

  4 weeks after treatment

• Time to Complete Wound Healing

  Time to complete wound healing is defined as the number of days from initial treatment to complete wound closure (100% re-epithelialization).

  Up to 6 months

Secondary Outcomes (4)

• Scar Assessment

  Month 3, month 6

• Pigmentation Assessment

  Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.

• Functional Recovery

  Month 6

• Quality of Life

  Month 6

Other Outcomes (1)

• Incidence of Adverse Events

  From enrollment to 6 months after treatment completion

Study Arms (2)

Combined Therapy Group

Patients receiving autologous epidermal cell suspension sprayed onto the wound bed immediately after dermabrasion or surgical debridement, followed by coverage with porcine xenograft as a temporary biological dressing.

Procedure: Autologous Epidermal Cell Suspension

Conventional Treatment Group

Patients receiving conventional treatment after dermabrasion or surgical debridement without autologous epidermal cell suspension, including but not limited to: porcine xenograft alone, autologous skin grafting, or standard dressing changes.

Interventions

Autologous Epidermal Cell Suspension PROCEDURE

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.

Combined Therapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from patients with second-degree burn wounds requiring dermabrasion or surgical debridement at the burn units or wound repair departments of multiple tertiary hospitals across China, with Sun Yat-sen University First Affiliated Hospital serving as the lead center. Eligible participants are those requiring surgical debridement and wound repair who meet the inclusion criteria. Patients in the combined therapy group will receive autologous epidermal cell suspension followed by porcine xenograft coverage. Patients in the conventional treatment group will receive standard care without cell suspension (e.g., xenograft alone, autologous skin grafting, or standard dressing changes). Group assignment is based on clinical practice and patient preference, not randomization. The study aims to reflect real-world clinical practice across diverse burn care settings.

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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04