NCT02362360已完成不适用
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
研究概览
简要总结
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
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
- •Have given written informed consent and in DK: signed a 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
- •Able to use a baseplate size 15 to 40 mm
- •Be able to handle the product themselves
- •Normally experience faeces under the baseplate at least 3 times during 2 weeks
- •Currently using a 2-piece flat product with mechanical coupling
- •Willing to test both the Coloplast test product and the comparator product
- •Willing to use an open bag size maxi during the investigation
- •Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
- •Willing to use at least 1 baseplate every 3rd day during the investigation
- •Is able to use a custom cut product
- •Be suitable for participating in the investigation
排除标准
- •Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
- •Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
- •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 peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- •Have a loop ostomy
- •Have known hypersensitivity towards any of the products used in the investigation
结局指标
主要结局
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".
时间窗: 21 +/- 3 days
Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".
次要结局
未报告次要终点
研究者
研究点 (10)
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