Investigation of a New 1-piece Convex Ostomy Product in Subjects With Ileostomy and Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Degree of Leakage
研究概览
简要总结
The aim of the investigation was to investigate the performance and safety of a new ostomy product
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
- •Are at least 18 years of age and have full legal capacity.
- •Have had an ileostomy/colostomy for more than 3 months
- •Have used a 1-piece flat ostomy product for the last 1 month
- •Has given written Informed Consent and signed the letter of authority
- •Have an ileostomy or colostomy with a diameter of 33 mm or less
- •Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
- •Are evaluated to be suitable for a soft convex product
- •If having a colostomy: changes their product on average 2 times pr. 24h or more
- •Currently uses a bag of size medi/midi or maxi
排除标准
- •Have a loop ostomy (also called double-barrel or ostomy with two outlets).
- •Are pregnant or breastfeeding
- •Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- •Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
- •Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- •Known hypersensitivity toward any of the test products
- •Participating in other interventional clinical investigations or have previously participated in this investigation
- •Use irrigation during the investigation (flush the intestine with water)
- •Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
- •If subject has a colostomy: empties the bag
研究组 & 干预措施
First Coloplast Test
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Coloplast Test; Secondly to either
- Own product (baseline)
- Competitor soft convex
干预措施: Coloplast Test (Device)
First Coloplast Test
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Coloplast Test; Secondly to either
- Own product (baseline)
- Competitor soft convex
干预措施: Own product (Device)
First Coloplast Test
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Coloplast Test; Secondly to either
- Own product (baseline)
- Competitor soft convex
干预措施: Competitor soft convex (Device)
First Competitor soft convex
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Competitor soft convex; Secondly to either
- Own product (baseline)
- Coloplast Test
干预措施: Coloplast Test (Device)
First Competitor soft convex
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Competitor soft convex; Secondly to either
- Own product (baseline)
- Coloplast Test
干预措施: Own product (Device)
First Competitor soft convex
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Competitor soft convex; Secondly to either
- Own product (baseline)
- Coloplast Test
干预措施: Competitor soft convex (Device)
First Own product
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Own product; Secondly to either
- Coloplast Test
- Competitor soft convex
干预措施: Coloplast Test (Device)
First Own product
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Own product; Secondly to either
- Coloplast Test
- Competitor soft convex
干预措施: Own product (Device)
First Own product
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods.
First subjects are allocated to Own product; Secondly to either
- Coloplast Test
- Competitor soft convex
干预措施: Competitor soft convex (Device)
结局指标
主要结局
Degree of Leakage
时间窗: 14 +/- 3 days
The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.
次要结局
未报告次要终点