Cell Suspension With Biologic Dressing for Burn Wounds
ConditionWound Healing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Autologous Epidermal Cell Suspension
Procedure/SurgeryA 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.
Treatment groups
386 Participants
are divided into 2 treatment groupsGroup A: Combined Therapy Group1 intervention
Group B: Conventional Treatment Group0 interventions
Trial outcomes
Primary outcomes
1
Wound Healing Rate at 4 Weeks
Proportion of wounds achieving complete epithelialization without drainage at 4 weeks post-treatment.
Time frame
4 weeks after treatment2
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 monthsSecondary outcomes
1
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 62
Pigmentation Assessment
Month 3, month 6
Time frame
Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.3
Functional Recovery
Assessment of functional status of the healed area, including range of motion for wounds over joints.
Time frame
Month 64
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 6Other outcomes
1
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).
Time frame
From enrollment to 6 months after treatment completionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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