A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Degree of Leakage
研究概览
简要总结
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
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
- •Had given written informed consent
- •Was at least 18 years of age
- •Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
- •Had an ileostomy with a diameter between 15-45 mm
- •Have had an ileostomy for at least 3 months
- •Currently used a 2-piece flat appliance
排除标准
- •Used irrigation during the investigation (flush stoma with water)
- •Currently received or had within the past 2 months received radio- and/or chemotherapy.
- •Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
- •Was pregnant or breast feeding
- •Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
- •Had a baseplate wear time of more than three days
- •Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)
研究组 & 干预措施
Coloplast Test A, Coloplast Test B, Own product
The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
干预措施: Coloplast Test A (Device)
Coloplast Test A, Coloplast Test B, Own product
The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
干预措施: Coloplast Test B (Device)
Coloplast Test A, Coloplast Test B, Own product
The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
干预措施: Own product (Device)
Coloplast Test C , Coloplast Test D, Own product
The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
干预措施: Own product (Device)
Coloplast Test C , Coloplast Test D, Own product
The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
干预措施: Coloplast Test C (Device)
Coloplast Test C , Coloplast Test D, Own product
The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
干预措施: Coloplast Test D (Device)
结局指标
主要结局
Degree of Leakage
时间窗: 14 days
Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).
次要结局
未报告次要终点