An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Leakage
研究概览
简要总结
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Be at least 18 years of age and have full legal capacity
- •Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
- •Have an ileostomy with a diameter between 15 and 45 mm
- •Have had their ostomy for at least three months
- •Currently use a 1-piece flat product with open bag
- •Use minimum 1 product every second day.
- •Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
- •Must use custom cut product
- •Accept to test two 1-piece products within the study
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 systemic steroid or local treatment in the peristomal area
- •Are pregnant or breastfeeding
- •Participating in other interventional clinical investigations or have previously participated in this investigation
- •Has more than three days wear time
研究组 & 干预措施
First Coloplast Test product; then Standard Care (see below)
The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
干预措施: Coloplast Test product (Device)
First Coloplast Test product; then Standard Care (see below)
The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
干预措施: Standard Care (Device)
First Standard Care (see below); Then coloplast test product
The subjects are randomised to test Standard care first and thereafter test Coloplast test product.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
干预措施: Coloplast Test product (Device)
First Standard Care (see below); Then coloplast test product
The subjects are randomised to test Standard care first and thereafter test Coloplast test product.
Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.
The three Standard Care products were tested in a 1:1:1 randomisation.
干预措施: Standard Care (Device)
结局指标
主要结局
Leakage
时间窗: 14+/-3 days per product
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
次要结局
未报告次要终点