Basement Membrane Regeneration for Wound Repair

Официальное название

A Prospective, Multicenter, Real-World Observational Study of Autologous Basement Membrane Regeneration Technology (Epidermal Basal Cell Suspension Using Cell Sorting System) for Wound Repair in Patients Undergoing Skin Grafting, Flap Surgery, or Primary Suture

Обзор

This study is a prospective, multicenter, real-world observational study. It aims to evaluate the effectiveness and safety of autologous basement membrane regeneration technology (epidermal basal cell suspension prepared using a cell sorting system) for wound repair in patients undergoing skin grafting, flap surgery, or primary suture. A total of 500 patients receiving the cell suspension therapy combined with standard surgical procedures will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients receiving standard surgical procedures alone (e.g., skin grafting, flap surgery, or suture without cell suspension). The primary outcomes include complete wound healing rate at 4 weeks (for grafted wounds) and time to complete wound closure (for sutured or flap-repaired wounds). Secondary outcomes include wound area reduction rate, recurrence rate, scar assessment (Vancouver Scar Scale), pain score (ASA), sweat function test, basement membrane integrity (histopathology with collagen IV and VII staining if clinically indicated), and safety. Patients will be followed for up to 6 months.

Вмешательства

• Процедура Autologous Epidermal Basal Cell Suspension
  A suspension of basal cells enriched from the patient's own split-thickness skin graft using a cell sorting system. The suspension contains epidermal basal cells and basement membrane components. It is applied to the wound bed or injected along suture lines to promote in situ basement membrane regeneration, enhance wound healing, and reduce scar formation.

Первичные конечные точки

• Complete Wound Healing Rate at 4 Weeks (for grafted wounds) [Срок оценки: 4 weeks after surgery]
• Time to Complete Wound Healing (for sutured or flap-repaired wounds) [Срок оценки: From surgery to complete healing, assessed up to 6 months]

Вторичные конечные точки (5)

• Wound Area Reduction Rate [Срок оценки: 2 weeks after surgery]
• Recurrence Rate [Срок оценки: 6 months after surgery]
• Scar Assessment [Срок оценки: Month 1, month 3, month 6]
• Pain Score [Срок оценки: Postoperative day 7, 14, month 1, 3, 6]
• Sweat Function Test [Срок оценки: Month 6]

Критерии участия

Критерии включения

• Patients with wounds requiring surgical repair (skin grafting, flap surgery, or primary suture), including but not limited to: burn wounds, traumatic wounds, post-surgical excision defects (e.g., scars, pigmentation disorders, skin tumors), and chronic wounds (diabetic ulcers, venous ulcers, pressure injuries, radiation ulcers, neuropathic ulcers, burn residual wounds, etc.).
• 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 surgery 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, rapidly progressive or advanced disease, or severe organ dysfunction (heart, lung, brain, etc.).
• Psychiatric disorder.
• Presence of diseases (e.g., malignant tumor, autoimmune disease) or use of medications (e.g., high-dose corticosteroids: ≥40 mg prednisone or equivalent per day for ≥2 weeks) that may affect wound healing.
• HIV positivity, clinical diagnosis of AIDS, or absolute neutrophil count (ANC) < 1000 cells/mm³ during screening.
• Pregnancy or breastfeeding.
• Active infection or necrosis of the wound (unless controlled after debridement).

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: NCT07551284 · SYSU-BM-REGEN-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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