NCT03619226已完成不适用
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Resistance (Moisture in the Adhesive)
研究概览
简要总结
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have intact skin on the area used in the evaluation
- •Have an abdominal area accessible for application of test product (assessed by investigator)
- •Negative pregnancy test for fertile women
- •Signed document claiming use of safe contraceptives for fertile women
排除标准
- •Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
- •Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
- •Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation
结局指标
主要结局
Resistance (Moisture in the Adhesive)
时间窗: 3 days
The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.
次要结局
未报告次要终点
研究者
研究点 (2)
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