NCT02486874已完成1 期
Clinical Evaluation of PoreSkin: A Human Acellular Dermal Matrix
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- The engraftment rate
研究概览
简要总结
PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine, Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a permanent dermal substitute aiming to reduce skin contracture. The objective of this study is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •18-60 years with burn scar contracture and hypertrophic scar
排除标准
- •Undergoing immunosuppressive therapy
- •Immunocompromise host (DM, HIV infected)
- •Evidence of malnutrition
- •Active malignancy
结局指标
主要结局
The engraftment rate
时间窗: 1 month
次要结局
- Any local complications(1 month)
- the final cosmetic result(1 month)
研究者
Apichai Angspatt
Apichai Angspatt
Chulalongkorn University
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