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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Complete Wound Healing Rate at 4 Weeks (for grafted wounds)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Basement Membrane Regeneration Group
Patients receiving autologous epidermal basal cell suspension (prepared using a cell sorting system from a split-thickness skin graft) combined with standard surgical procedures. The cell suspension is sprayed onto the wound bed before skin grafting or injected continuously at points along both sides of the suture line after flap surgery or tension-reducing suture to promote in situ basement membrane regeneration.
干预措施: Autologous Epidermal Basal Cell Suspension (Procedure)
Conventional Surgery Group
Patients receiving standard surgical procedures alone (skin grafting, flap surgery, or primary suture) without autologous epidermal basal cell suspension. Wound debridement, dressing changes, and postoperative care are identical to the experimental group.
结局指标
主要结局
Complete Wound Healing Rate at 4 Weeks (for grafted wounds)
时间窗: 4 weeks after surgery
Proportion of skin graft recipient sites achieving complete epithelialization without drainage at 4 weeks post-surgery.
Time to Complete Wound Healing (for sutured or flap-repaired wounds)
时间窗: From surgery to complete healing, assessed up to 6 months
Number of days from surgery to complete wound closure (100% re-epithelialization or suture removal without dehiscence) for primarily sutured wounds or flap-repaired wounds.
次要结局
- Wound Area Reduction Rate(2 weeks after surgery)
- Recurrence Rate(6 months after surgery)
- Scar Assessment(Month 1, month 3, month 6)
- Pain Score(Postoperative day 7, 14, month 1, 3, 6)
- Sweat Function Test(Month 6)
研究者
Hu Zhicheng
Professor
First Affiliated Hospital, Sun Yat-Sen University