Evaluation of Adhesion Properties in Wound Care Devices
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peel Off Force
研究概览
简要总结
Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
all participants will receive the same up to 12 test samples, which are randomized intra-individual.
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed eligibility and signed consent form.
排除标准
- •Known plaster allergy or other known contact hypersensitivity
- •Pregnant or breastfeeding individual.
研究组 & 干预措施
Self-adhesive wound care devices
test devices with adhesive material to be attached to skin
干预措施: self-adhesive device (Other)
结局指标
主要结局
Peel Off Force
时间窗: up to 48 hours
Internal machine shall measure the peel force expressed in Newton.
次要结局
- Humidity(up to 48 hours)
- Redness(up to 48 hours)
- Pain assessment(up to 48 hours)