Cell Suspension With Biologic Dressing for Burn Wounds

N/ANot Yet RecruitingNCT07555418

First Affiliated Hospital, Sun Yat-Sen University386 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

386

Conditions

Wound Healing

Interventions

Autologous Epidermal Cell SuspensionPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Wound Healing Rate at 4 Weeks

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

Time frame: 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).

Time frame: Up to 6 months

Secondary Outcomes

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.

Time frame: Month 3, month 6

Pigmentation Assessment

Month 3, month 6

Time frame: 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.

Time frame: 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.

Time frame: Month 6