NCT03001531已完成不适用
Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Swiss Paraplegic Research, Nottwil1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- presence of burn injury
研究概览
简要总结
Preconditioning of regional skin is known to reduce post surgery complications due to increased perfusion and better skin condition. The aim of this study is to prove that local heating through a standardized device in patients with spinal cord injury induces no burnings or other relevant side effects. The investigators expect an increased regional perfusion, temperature and redness.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women
- •aged from 18 to 65 years
- •paraplegia Th2-Th12
- •spinal cord injury had occurred >12 weeks ago
排除标准
- •infections
- •heart failure stadium III
- •renal insufficiency stadium III.
- •scars, wounds or other injuries in the area of treatment
- •skin type V and VI on Fitzpatrick scale
结局指标
主要结局
presence of burn injury
时间窗: up to 24 hours
grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)
次要结局
- blood perfusion(before and 1min after the application of light or heat)
- skin redness(before and 1min after the application of light or heat)
- skin surface temperature(before and 1min after the application of light or heat)
研究者
研究点 (1)
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