Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Degree of Leakage
研究概览
简要总结
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
详细描述
The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.
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 form.
- •Be at least 18 years of age and have full legal capacity.
- •Be able to handle the bags themselves.
- •Have an ileostomy with a diameter between 15 and 40 mm.
- •Have had their ostomy for at least three months.
- •Currently use a 1-piece flat ostomy appliance with open bag.
- •Use minimum 1 ostomy appliance every second day.
- •Be suitable for participation in the investigation and for using standard adhesive, flat base plate.
- •Must be able to use a custom cut ostomy appliance.
- •Accept to test three 1-piece ostomy appliances in the investigation.
- •Negative result of a pregnancy test for women of childbearing age (only DK).
排除标准
- •Use irrigation during the study (flush the stoma with water).
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •Currently receiving or have within the past months received local or systemic steroid treatment in the peristomal area.
- •Are pregnant or breastfeeding.
- •Participating in other interventional clinical investigations or have previously participated in this investigation.
- •Currently using ostomy belt.
- •Currently using extended wear product.
- •Known hypersensitivity towards any of the test products
- •Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -
研究组 & 干预措施
Treatment sequence 2
The subjects randomised to Treatment sequence 2 are going to test
- Coloplast Adhesive baseplate B (B)
- Coloplast Adhesive baseplate C (C)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: CBS; BSC; SCB
干预措施: Coloplast Adhesive baseplate B (Device)
Treatment sequence 2
The subjects randomised to Treatment sequence 2 are going to test
- Coloplast Adhesive baseplate B (B)
- Coloplast Adhesive baseplate C (C)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: CBS; BSC; SCB
干预措施: Coloplast Adhesive baseplate C (Device)
Treatment sequence 2
The subjects randomised to Treatment sequence 2 are going to test
- Coloplast Adhesive baseplate B (B)
- Coloplast Adhesive baseplate C (C)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: CBS; BSC; SCB
干预措施: SenSura 1-Piece (Device)
Treatment sequence 3
The subjects randomised to Treatment sequence 3 are going to test
- Coloplast Adhesive baseplate A (A)
- Coloplast Adhesive baseplate B (C)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: ACS; CSA; SAC
干预措施: Coloplast Adhesive baseplate A (Device)
Treatment sequence 3
The subjects randomised to Treatment sequence 3 are going to test
- Coloplast Adhesive baseplate A (A)
- Coloplast Adhesive baseplate B (C)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: ACS; CSA; SAC
干预措施: Coloplast Adhesive baseplate C (Device)
Treatment sequence 3
The subjects randomised to Treatment sequence 3 are going to test
- Coloplast Adhesive baseplate A (A)
- Coloplast Adhesive baseplate B (C)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: ACS; CSA; SAC
干预措施: SenSura 1-Piece (Device)
Treatment sequence 1
The subjects randomised to Treatment sequence 1 are going to test
- Coloplast Adhesive baseplate A (A)
- Coloplast Adhesive baseplate B (B)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: ABS; BSA; SAB
干预措施: Coloplast Adhesive baseplate A (Device)
Treatment sequence 1
The subjects randomised to Treatment sequence 1 are going to test
- Coloplast Adhesive baseplate A (A)
- Coloplast Adhesive baseplate B (B)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: ABS; BSA; SAB
干预措施: Coloplast Adhesive baseplate B (Device)
Treatment sequence 1
The subjects randomised to Treatment sequence 1 are going to test
- Coloplast Adhesive baseplate A (A)
- Coloplast Adhesive baseplate B (B)
- SenSura 1-piece (S)
The subjects test the three test products in a randomised order: ABS; BSA; SAB
干预措施: SenSura 1-Piece (Device)
结局指标
主要结局
Degree of Leakage
时间窗: one week
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage
次要结局
未报告次要终点