NCT02176954已完成不适用
The Influence of Adhesive Wafer Design on Fit to the Body
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 20
- 主要终点
- Fit to body
研究概览
简要总结
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
- •Have given written informed consent and signed letter of Authority
- •Be at least 18 years of age and have full legal capacity
- •Have had their ileostomy or colostomy for at least 3 months
- •Have a stoma with a diameter between 15 and 43 mm
- •Be able to handle the product themselves
- •Be able to use a custom cut product
- •Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks
- •Currently using a 1-piece flat product or a 1-piece soft convex product
- •Be willing to test products with open bag size maxi
- •Be willing to test Moderma Flex or Confidence® Natural, Drainable and the two test products A and B
- •Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product
- •Be suitable for participating in the investigation
- •Be willing to take/have taken pictures of the stoma before, during and after application of product
排除标准
- •Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
- •Are currently receiving or have within the past 2 months received radio-and/or chemotherapy
- •Are currently receiving or have within the past month received topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment
- •Are pregnant or breastfeeding
- •Are participating in other interventional clinical investigations or have previously participated in this investigation
- •Use irrigation during the investigation (flush the intestines with water)
- •Are currently suffering from peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse)
- •Have a loop stoma
- •Have known hypersensitivity towards any of the test products
结局指标
主要结局
Fit to body
时间窗: 14 +/- 2 days
Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?" The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score.
次要结局
未报告次要终点
研究者
研究点 (20)
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