NCT01957462已完成不适用
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Degree of Leakage
研究概览
简要总结
The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
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 signed letter of authority.
- •Are at least 18 years of age and have full legal capacity.
- •Have had their ostomy (ileo- or colostomy) for at least 3 months.
- •Have used a 1-piece convex ostomy product during the last month.
- •Are willing and able to comply with investigation procedures.
- •Have a ostomy with a diameter of 33 mm or less.
排除标准
- •Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- •Currently receiving or have within the past 2 month received radio- and/or chemotherapy.
- •Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.
- •Are pregnant or breastfeeding.
- •Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- •Known hypersensitivity toward any of the test products.
- •Use irrigation during the investigation (flush the stoma with water).
- •Participating in other interventional clinical investigations or have previously participated in this investigation.
结局指标
主要结局
Degree of Leakage
时间窗: 14 days
The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change
次要结局
未报告次要终点
研究者
研究点 (2)
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