An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Leakage Under the Base Plate Using a 24-point Scale
研究概览
简要总结
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age > 18 years.
- •Have had an ileostomy for more than 3 months.
- •Have used convex products for the last 1 month.
- •Has given written Informed Consent.
- •Have an ileostomy with a diameter between 15 and 33 mm.
- •Have inward peristomal area
排除标准
- •Have loop ostomy
- •Pregnant or breastfeeding.
- •Known allergy towards any of the product components or ingredients.
- •Currently receiving or have within the last 2 months received radio- and/or chemotherapy.
- •Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- •Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
研究组 & 干预措施
test product 1 first
own product (baseline) - test product 1 - test product 2
test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1
干预措施: test product 1: new ostomy base plate with Coloplast as manufacturer (Device)
test product 2 first
own product (baseline) - test product 2 - test product 1
test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2
干预措施: test product 2: new ostomy base plate with Coloplast as manufacturer (Device)
结局指标
主要结局
Leakage Under the Base Plate Using a 24-point Scale
时间窗: Each product will be tested 2 weeks
Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)
次要结局
未报告次要终点