The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Degree of Leakage
研究概览
简要总结
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
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
- •Be at least 18 years of age and have full legal capacity
- •Have had their ileostomy/colostomy for at least 3 months
- •Have a stoma with a diameter between 15 and 36 mm
- •Be able to handle the products themselves
- •Be able to use a custom cut product
- •Normally experience faeces under the base plate at least 3 times during 2 weeks
- •Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut
- •Be willing to test the test products without using paste and/or ring
- •Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct
- •Be suitable for participation in the investigation
- •Be able to present a negative result of a pregnancy test - for women of childbearing age
排除标准
- •Are currently receiving or have within the past 2 months received radio- and/or chemotherapy
- •Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area
- •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)
- •Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)
- •Have a loop stoma
- •Have known hypersensitivity towards any of the test products (including adhesive remover)
研究组 & 干预措施
First Coloplast Teast A; then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Coloplast Test A (Device)
First Coloplast Teast A; then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Coloplast Test B (Device)
First Coloplast Teast A; then Coloplast Test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Standard product (Device)
First Coloplast Test A; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Coloplast Test A (Device)
First Coloplast Test A; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Coloplast Test B (Device)
First Coloplast Test A; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Standard product (Device)
First Coloplast Test B; Then Colopast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Coloplast Test A (Device)
First Coloplast Test B; Then Colopast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Coloplast Test B (Device)
First Coloplast Test B; Then Colopast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Standard product (Device)
First Coloplast Test B; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Coloplast Test A (Device)
First Coloplast Test B; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Coloplast Test B (Device)
First Coloplast Test B; Then Standard product
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Standard product (Device)
First Standard product; Then Coloplast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Coloplast Test A (Device)
First Standard product; Then Coloplast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Coloplast Test B (Device)
First Standard product; Then Coloplast Test A
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B
干预措施: Standard product (Device)
First Standard Product, Then Coloplast test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Coloplast Test A (Device)
First Standard Product, Then Coloplast test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Coloplast Test B (Device)
First Standard Product, Then Coloplast test B
There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.
The test sequence in this arm is:
Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A
干预措施: Standard product (Device)
结局指标
主要结局
Degree of Leakage
时间窗: 10 (- 2 days)
The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
次要结局
未报告次要终点