Cell Suspension With Biologic Dressing for Burn Wounds

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Procedure: Autologous Epidermal Cell Suspension

• Study Type: Observational
• Enrollment (Estimated): 386

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Assessment	Scar quality is evaluated using the Vancouver Scar Scale (VSS) or the Patient and Observer Scar Assessment Scale (POSAS), per site standard or investigator discretion. Scale specifications: VSS: Scores range from 0 to 13, where higher scores indicate worse scar outcome (0 = normal skin, 13 = worst possible scar). POSAS: Consists of Observer Scale (6 items: vascularity, pigmentation, thickness, relief, pliability, surface area) and Patient Scale (6 items: pain, itching, color, stiffness, thickness, irregularity). Each item is scored 1-10 (1 = normal skin/no complaint, 10 = worst imaginable). Total score ranges from 6 to 60. Higher scores indicate worse scar outcome.	Month 3, month 6
Pigmentation Assessment	Month 3, month 6	Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.
Functional Recovery	Assessment of functional status of the healed area, including range of motion for wounds over joints.	Month 6
Quality of Life	Quality of life is assessed using a validated questionnaire, the Burn Specific Health Scale-Brief (BSHS-B). Scale specifications: The BSHS-B consists of multiple domains (e.g., physical function, psychological function, social function, general health, and work). Each item is scored on a 0-4 scale (0 = extreme problem, 4 = no problem). Domain and total scores are transformed to a 0-100 scale, where higher scores indicate better quality of life.	Month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Proportion of participants experiencing local adverse reactions (erythema, edema, exudation, infection, rejection signs, rash, itching, allergy) or systemic adverse reactions (fever, systemic infection).	From enrollment to 6 months after treatment completion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SYSU-CELL-SKIN-2026-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No