NCT03257774已完成不适用
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Output
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Trans epidermal water loss
研究概览
简要总结
The study investigates the impanct real output has on the adhesion of a new adhesive
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
- 否
入选标准
- •Have given written informed consent
- •Be at least 18 years of age and have full legal capacity
- •Have had a stoma for more than one year
- •Have intact skin on the area used in the evalua-tion
- •Has a stoma with a diameter up to (≤) 35 mm
- •Have a peristomal area accessible for application of adhesive strips (assessed by investigating scientist)
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 peristomal skin area or systemic steroid (tablet/injection) treatment.
- •Are pregnant or breastfeeding
- •Having dermatological problems in the peristo-mal- or abdominal area (assessed by investigating scientist)
- •Actively participating in other interventional clinical investigations or have previously participated in this investigation
研究组 & 干预措施
Test of three new adhesive strips
Experimental
The subjects test three new adhesive strips
- adhesive strip A
- adhesive strip B
- adhesive strip C
干预措施: Adhesive strip A (Other)
Test of three new adhesive strips
Experimental
The subjects test three new adhesive strips
- adhesive strip A
- adhesive strip B
- adhesive strip C
干预措施: Adhesive strip B (Other)
Test of three new adhesive strips
Experimental
The subjects test three new adhesive strips
- adhesive strip A
- adhesive strip B
- adhesive strip C
干预措施: Adhesive strip C (Other)
结局指标
主要结局
Trans epidermal water loss
时间窗: 8 hours
The trans epidermal water loss is measured on the peristomal skin using a probe. Thrans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin du to natural evaporation. However, when the skin barrier is damaged more water can evaporate. Trans epridermal water loss is used to assess the damage to the skin.
次要结局
未报告次要终点
研究者
研究点 (1)
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