NCT05415059Unknown不适用
Laryngeal, Endotracheal Airway Fixator (LEAFix): In Vivo Skin Adhesion Verification Protocol
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Adhesion after 24 hours
研究概览
简要总结
This study compares the adhesiveness of the 3M material to be used in the final design.
详细描述
The material is taken from a CE marked stoma bag. Strips will be placed on to healthy volunteers on the arm and face for 10 minutes and 24 hours. A force gauge will measure the peel force. This will be compared to previous testing on metal.
Participants will also be assessed and followed up for any adverse skin issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Healthy volunteers
- •Not been in a trial in last 12 weeks
- •mild to no skin issues
排除标准
- •any significant allergies
- •any allergies to skin adhesive
- •any medium to severe skin issues
结局指标
主要结局
Adhesion after 24 hours
时间窗: 24 hours
Adhesion after 24 hours of placement inferred from peel force measured with a force gauge at 10 minutes and 24 hours measured in Newtons (N)
次要结局
- Skin outcomes(7 days)
研究者
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