Thermotape High-adhesion Medical Tape Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pain Experienced by Tape Removal
研究概览
简要总结
This objective of this study is to compare the safety and performance of Thermotape compared to Tegaderm™ tape and Kind™ tape over the course of 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants should be between 18 to 25 years of age.
排除标准
- •Participants with history of eczema or medical related skin injuries (MARSI), allergic to adhesives, and/or have a wound or rash on their skin will be excluded.
结局指标
主要结局
Pain Experienced by Tape Removal
时间窗: Each removal and assessment would take at maximum 5 minutes.
A 0 to 10 point Wong-Baker FACES Pain Rating Scale will be used to quantify the pain felt by the subject when each tape is removed. A score of 0 represents no pain experienced by removal, while 10 represents severe pain experienced during tape removal.
Skin Irritation
时间窗: Subjects will wait approximately 15 minutes before leaving, to ensure that irritation has occurred.
Redness of the skin will be examined after tape is removed.
次要结局
- Skin cells(The removal of each tape will take a maximum of 2 minutes.)
- Trans-epidermal Water Loss(The removal of each tape will take a maximum of 2 minutes.)
- Wear(The removal of each tape will take a maximum of 2 minutes.)
- Hair Follicles(The removal of each tape will take a maximum of 2 minutes.)
研究者
Eric Seibel
Research Professor: Mechanical Engineering
University of Washington