Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept 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
- 32
- 试验地点
- 2
- 主要终点
- Leakage (Percentage of All Baseplates With Leakage)
研究概览
简要总结
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
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
- •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 55 mm
- •Have had their ileostomy for at least 3 months
- •Currently use a 1-piece flat ostomy appliance with open bag
- •Use minimum 1 product every second day, i.e. maximum 2 days wear time
- •Be suitable for participation in the study and for using a standard adhesive, flat base plate
- •Must be able and willing to use custom cut products
- •Accept to test two 1-piece products within the study period
排除标准
- •Use irrigation during the study period (flush the intestines with water)
- •Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
- •Currently receiving or have within the past month received systematic 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
- •Currently using a ostomy belt
- •Currently using extended wear product
- •Have a loop ileostomy
- •Known hypersensitivity towards any of the test products
- •Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)
结局指标
主要结局
Leakage (Percentage of All Baseplates With Leakage)
时间窗: After each baseplate change over a period, of 7 days
leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)
次要结局
未报告次要终点