Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Degree of Leakage
研究概览
简要总结
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
详细描述
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a 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
- •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 appliances themselves
- •Have an ileostomy with a diameter between 15 and 40 mm.
- •Have had their ostomy for at least three months.
- •Use minimum 1 baseplate every third day.
- •Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
- •Must be able to use custom cut product
- •Accept to test three 2-piece products within the study.
- •Negative result of a pregnancy test for women of childbearing age.
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 month 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.
- •More than three days wear time as usual change pattern.
- •Currently using ostomy belt
- •Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
- •Have a loop ileostomy
- •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 1
Subjects randomised to Treatment sequence 1 will test three different products:
- Coloplast A
- Coloplast B
- SenSura Click
The subjects test the three test products in a randomized order: ABS; BSA, SAB
干预措施: Coloplast A (Device)
Treatment sequence 1
Subjects randomised to Treatment sequence 1 will test three different products:
- Coloplast A
- Coloplast B
- SenSura Click
The subjects test the three test products in a randomized order: ABS; BSA, SAB
干预措施: Coloplast B (Device)
Treatment sequence 1
Subjects randomised to Treatment sequence 1 will test three different products:
- Coloplast A
- Coloplast B
- SenSura Click
The subjects test the three test products in a randomized order: ABS; BSA, SAB
干预措施: SenSura Click (Device)
Treatment sequence 2
Subjects randomised to Treatment sequence 2 will test three different products:
- Coloplast C (C)
- Coloplast B (B)
- SenSura Click (S)
The subjects test the three test products in a randomized order: CBS; BSC, SCB
干预措施: Coloplast B (Device)
Treatment sequence 2
Subjects randomised to Treatment sequence 2 will test three different products:
- Coloplast C (C)
- Coloplast B (B)
- SenSura Click (S)
The subjects test the three test products in a randomized order: CBS; BSC, SCB
干预措施: Coloplast C (Device)
Treatment sequence 2
Subjects randomised to Treatment sequence 2 will test three different products:
- Coloplast C (C)
- Coloplast B (B)
- SenSura Click (S)
The subjects test the three test products in a randomized order: CBS; BSC, SCB
干预措施: SenSura Click (Device)
Treatment sequence 3
Subjects randomised to Treatment sequence 3 will test three different products:
- Coloplast A (A)
- Coloplast C (C)
- SenSura Click (S)
The subjects test the three test products in a randomized order: ACS; CSA, SAC
干预措施: Coloplast A (Device)
Treatment sequence 3
Subjects randomised to Treatment sequence 3 will test three different products:
- Coloplast A (A)
- Coloplast C (C)
- SenSura Click (S)
The subjects test the three test products in a randomized order: ACS; CSA, SAC
干预措施: Coloplast C (Device)
Treatment sequence 3
Subjects randomised to Treatment sequence 3 will test three different products:
- Coloplast A (A)
- Coloplast C (C)
- SenSura Click (S)
The subjects test the three test products in a randomized order: ACS; CSA, SAC
干预措施: SenSura Click (Device)
结局指标
主要结局
Degree of Leakage
时间窗: 10 days
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change
次要结局
未报告次要终点