NCT04374890Unknown不适用
Evaluation of a New Supporting Ostomy Product
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Wear time
研究概览
简要总结
The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Have had a stoma for more than three months
- •Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
- •Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm)
- •Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
- •Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
- •Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods
- •Have self-reported problems with leakage* (three times within 14 days) *Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)
排除标准
- •Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- •Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
- •Are pregnant or breastfeeding
- •Participating in other interventional clinical investigations or have previously participat-ed in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP308) protocol
- •Known sensitivity towards test product
- •Known sensitivity towards acrylate
- •Users with a pacemaker
结局指标
主要结局
Wear time
时间窗: 9 weeks
To evaluate the subject change pattern (wear time) when using the supporting product in 'real-life' situations'
次要结局
未报告次要终点
研究者
研究点 (2)
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