An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Peel force used to removed adhesive
研究概览
简要总结
The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 investigation
排除标准
- •Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- •Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Having dermatological problems in the abdominal area (assessed by investigator)
- •Participate in other clinical investigations or have previously participated in this investigation
研究组 & 干预措施
Strip A (wet)
Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)
干预措施: Strip A (Other)
Strip A (dry)
Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)
干预措施: Strip A (Other)
Strip B (wet)
Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)
干预措施: Strip B (Other)
Strip B (dry)
Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)
干预措施: Strip B (Other)
Strip C (wet)
Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)
干预措施: Strip C (Other)
Strip C (dry)
Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)
干预措施: Strip C (Other)
结局指标
主要结局
Peel force used to removed adhesive
时间窗: 60 min
The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured. Peel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90°
次要结局
未报告次要终点
