NCT03423134已完成不适用
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put
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
This study investigates the performance 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 evaluation
- •Has a stoma with a diameter up to (≤) 35 mm
- •Have a peristomal area accessible for application of patches/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 peristomal- or abdominal area (assessed by investigating scientist)
- •Actively participating in other interventional clinical investigations or have previously participated in this investigation.
- •Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)
研究组 & 干预措施
Test of new adhesive strip
Experimental
A new adhesive strip will be tested in this investigation
干预措施: New adhesive strip (Other)
结局指标
主要结局
trans epidermal water loss
时间窗: 24 hours
The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage
次要结局
未报告次要终点
研究者
研究点 (1)
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