Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Complete Wound Healing Rate
研究概览
简要总结
This multicenter real-world study evaluates the efficacy and safety of a novel technique for rapid intraoperative construction of tissue-engineered skin using autologous epidermal stem cells （EpiSCs） for repairing difficult-to-heal wounds. Eligible patients are randomized to receive either: （1） the experimental intervention （rapidly constructed EpiSCs-loaded scaffold combined with split-thickness skin graft via one-step or two-step procedure）， or （2） control intervention （acellular scaffold combined with split-thickness skin graft）. The primary outcome is the complete wound healing rate at 4 weeks post-surgery. Secondary outcomes include wound recurrence, scar quality （VSS/POSAS）， functional recovery （sweat test）， mortality, amputation rate, and safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All-age population
- •Wounds requiring surgical repair （single area 10-100 cm²）： acute wounds （burns, traumatic defects, post-scar resection） OR chronic wounds （diabetic foot ulcers, pressure injuries, vascular ulcers）
- •Completed wound bed preparation （no necrotic tissue, infection controlled）
- •Signed informed consent and agreement to use tissue-engineered materials and long-term follow-up
排除标准
- •History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials
- •Severe immunosuppression （HIV/AIDS, long-term immunosuppressant use）
- •Malignant tumors, uncontrolled systemic infection （CRP > 50 mg/L）， or organ failure （Child-Pugh Class C）
- •Mental illness preventing compliance with treatment or follow-up
- •Pregnant or lactating women
研究组 & 干预措施
Rapid Tissue-Engineered Skin Group
Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）
干预措施: Rapid Tissue-Engineered Skin (Procedure)
Traditional Composite Skin Graft Group
干预措施: Traditional Composite Skin Graft (Procedure)
结局指标
主要结局
Complete Wound Healing Rate
时间窗: At 4 weeks post-surgery
The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）
次要结局
- Wound Recurrence Rate(3, 6, 12 months post-surgery)
- Scar Quality Assessment(4 weeks, 3, 6, 12 months post-surgery)
- Functional Recovery(6, 12 months post-surgery)
- Mortality Rate(3, 6, 12 months post-surgery)
- Amputation Rate(3, 6, 12 months post-surgery)
- Healing Trajectory(1, 2, 3 weeks post-surgery)
- Safety Outcome(From day of surgery through 12 months post-surgery)
研究者
Hu Zhicheng
Clinical Professor
First Affiliated Hospital, Sun Yat-Sen University