Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 23
- 主要终点
- Fit to Body
研究概览
简要总结
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
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 in DK: signed a letter of authority
- •Are at least 18 years of age and have full legal capacity
- •Have had their ileostomy or colostomy for at least 3 months
- •Are able to use a baseplate cut-max 15 to 40 mm
- •Are able to handle the product themselves
- •Currently using a 1-piece flat product
- •Willing to use an open bag size maxi during the investigation
- •Are able to use a custom cut (custom fit) product
- •Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.
排除标准
- •Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- •Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- •Are pregnant or breastfeeding**
- •Are participating in other interventional clinical investigations or have previously participated in this investigation
- •Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
- •Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- •Have a loop ostomy (also called double barrel ostomy)
- •Have known hypersensitivity towards any of the products used in the investigation
- •In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.
研究组 & 干预措施
Test A, Test B, Subjects own product
The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product
干预措施: Coloplast Test A (Device)
Test A, Test B, Subjects own product
The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product
干预措施: Coloplast Test B (Device)
Test A, Test B, Subjects own product
The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product
干预措施: Subjects own product (Device)
Test A, Subjects own product, Test B
The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B
干预措施: Coloplast Test A (Device)
Test A, Subjects own product, Test B
The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B
干预措施: Coloplast Test B (Device)
Test A, Subjects own product, Test B
The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B
干预措施: Subjects own product (Device)
Test B, Test A, Subjects own product
The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product
干预措施: Coloplast Test A (Device)
Test B, Test A, Subjects own product
The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product
干预措施: Coloplast Test B (Device)
Test B, Test A, Subjects own product
The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product
干预措施: Subjects own product (Device)
Test B, Subjects own product, Test A
The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A
干预措施: Coloplast Test A (Device)
Test B, Subjects own product, Test A
The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A
干预措施: Coloplast Test B (Device)
Test B, Subjects own product, Test A
The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A
干预措施: Subjects own product (Device)
Subjects own product, Test A, Test B
The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B
干预措施: Coloplast Test A (Device)
Subjects own product, Test A, Test B
The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B
干预措施: Coloplast Test B (Device)
Subjects own product, Test A, Test B
The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B
干预措施: Subjects own product (Device)
Subjects own product, Test B, Test A
The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A
干预措施: Coloplast Test A (Device)
Subjects own product, Test B, Test A
The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A
干预措施: Coloplast Test B (Device)
Subjects own product, Test B, Test A
The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A
干预措施: Subjects own product (Device)
结局指标
主要结局
Fit to Body
时间窗: 14 +/- 2 days
Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.
次要结局
未报告次要终点