Cell Suspension With Biologic Dressing for Burn Wounds

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Wound Healing Rate at 4 Weeks [Срок оценки: 4 weeks after treatment]
• Time to Complete Wound Healing [Срок оценки: Up to 6 months]

Вторичные конечные точки (4)

• Scar Assessment [Срок оценки: Month 3, month 6]
• Pigmentation Assessment [Срок оценки: Evaluation of hyperpigmentation or hypopigmentation in the healed wound area.]
• Functional Recovery [Срок оценки: Month 6]
• Quality of Life [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07555418 · SYSU-CELL-SKIN-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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