NCT01957475已完成不适用
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 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 2-piece convex ostomy appliances
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 ileostomy for at least 3 months.
- •Have used a 2-piece convex ostomy product during the last month.
- •Are willing and able to comply with investigation procedures.
- •Have an ileostomy with a diameter of 30 mm or less.
- •Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.
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.
- •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 (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was 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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