Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 4
- 主要终点
- Leakage
研究概览
简要总结
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
详细描述
The present investigation aims at testing the performance and safety of the two new 1-piece 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 (mandatory in DK)
- •Be at least 18 years of age and have full legal capacity.
- •Be able to handle the products themselves
- •Have an ileostomy with a diameter between 10 and 40 mm.
- •Have had their ostomy for at least three months.
- •Have within the last month used a 1-piece flat product with open bag
- •Currently using midi or maxi bags
- •Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
- •Be suitable for participation in the investigation
- •Must be able to use custom cut product
- •Negative result of a pregnancy test for women of childbearing age (only DK)
排除标准
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
- •Are pregnant or breastfeeding
- •Participating in other interventional clinical investigations or have previously participated in this investigation
- •Has participated in the previous explorative Coloplast studies CP236 and CP237
- •Are currently or during the study using ostomy belt
- •Has a stoma below skin surface
- •Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
- •Has known hypersensitivity towards any of the test products
研究组 & 干预措施
Treatment sequence 1; First Coloplast Test product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 1 and secondly test either:
- Coloplast Test product 1 and thereafter Coloplast SenSura
- Coloplast Sensura and thereafter Coloplast Test product 2
干预措施: Coloplast Test Product 1 (Device)
Treatment sequence 1; First Coloplast Test product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 1 and secondly test either:
- Coloplast Test product 1 and thereafter Coloplast SenSura
- Coloplast Sensura and thereafter Coloplast Test product 2
干预措施: Coloplast Test Product 2 (Device)
Treatment sequence 1; First Coloplast Test product 1
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 1 and secondly test either:
- Coloplast Test product 1 and thereafter Coloplast SenSura
- Coloplast Sensura and thereafter Coloplast Test product 2
干预措施: Coloplast SenSura (Device)
Treatment seqence 2; First Coloplast Test product 2.
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 2 and secondly test either:
- Coloplast Test product 1 and thereafter Coloplast SenSura
- Coloplast Sensura and thereafter Coloplast Test product 1
干预措施: Coloplast Test Product 1 (Device)
Treatment seqence 2; First Coloplast Test product 2.
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 2 and secondly test either:
- Coloplast Test product 1 and thereafter Coloplast SenSura
- Coloplast Sensura and thereafter Coloplast Test product 1
干预措施: Coloplast Test Product 2 (Device)
Treatment seqence 2; First Coloplast Test product 2.
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast Test product 2 and secondly test either:
- Coloplast Test product 1 and thereafter Coloplast SenSura
- Coloplast Sensura and thereafter Coloplast Test product 1
干预措施: Coloplast SenSura (Device)
Treatment sequence 3, First Coloplast SenSura
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast SenSura and secondly test either:
- Coloplast Test product 2 and thereafter Coloplast Test product 1
- Coloplast Test product 1 and thereafter Coloplast Test product 2
干预措施: Coloplast Test Product 1 (Device)
Treatment sequence 3, First Coloplast SenSura
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast SenSura and secondly test either:
- Coloplast Test product 2 and thereafter Coloplast Test product 1
- Coloplast Test product 1 and thereafter Coloplast Test product 2
干预措施: Coloplast Test Product 2 (Device)
Treatment sequence 3, First Coloplast SenSura
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.
Subjects are first allocated to test Coloplast SenSura and secondly test either:
- Coloplast Test product 2 and thereafter Coloplast Test product 1
- Coloplast Test product 1 and thereafter Coloplast Test product 2
干预措施: Coloplast SenSura (Device)
结局指标
主要结局
Leakage
时间窗: 14 +- 1 days
The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
次要结局
未报告次要终点