Cell Suspension With Biologic Dressing for Burn Wounds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Epidermal Cell Suspension.
- Who it may be relevant to
- Registry conditions: Wound Healing. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- 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.
Primary outcome measures
- Wound Healing Rate at 4 Weeks [Time frame: 4 weeks after treatment]
- Time to Complete Wound Healing [Time frame: Up to 6 months]
Secondary outcome measures (4)
- Scar Assessment [Time frame: Month 3, month 6]
- Pigmentation Assessment [Time frame: Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.]
- Functional Recovery [Time frame: Month 6]
- Quality of Life [Time frame: Month 6]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07555418 · SYSU-CELL-SKIN-2026-01