Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 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.
研究组 & 干预措施
FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
干预措施: Coloplast Test V (Device)
FirstColplast Test V, Then Coloplast Test X
The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X
干预措施: Coloplast Test X (Device)
First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
干预措施: Coloplast Test V (Device)
First Coloplast Test X, Then Coloplast Test V
The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V
干预措施: Coloplast Test X (Device)
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