NCT04171661进行中（未招募）早期 1 期
SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa
CHU de Quebec-Universite Laval1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年12月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percent reduction in wound surface area
研究概览
简要总结
Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This clinical trial was custom designed for one patient
排除标准
- 未提供
研究组 & 干预措施
SASS
Experimental
SASS applied on chronic skin wounds as skin graft
干预措施: SASS (Biological)
结局指标
主要结局
Percent reduction in wound surface area
时间窗: 2 weeks
Clinical assessment
次要结局
- Changes in pain scores(3 years)
- Graft failure(2 weeks)
- Time (in weeks) to 50% reduction in the surface area of the wounds;(3 years)
- Number of subsequent re-transplantation(3 years)
- Time (in weeks) to complete healing(3 years)
- Changes in itch scores where 0 is none and 10 the worst itch(3 years)
研究者
研究点 (1)
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