Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Leakage (Percent of All Base Plates With Leakage)
研究概览
简要总结
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
详细描述
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems.
To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics.
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
The study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and SenSura). Each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. The participants will visit the study investigator at study start and at cross-over. Evaluation of the test products will occur via questionnaires the subjects fill in at home.
50 healthy subjects with a colostomy will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 (application, removal)
- •Have a colostomy with a diameter less than 45 mm
- •Have had a colostomy for at least 3 months
- •Currently use a 1-piece flat ostomy appliance with closed bag
- •is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse)
- •Use minimum 1 product per day
- •Be willing to test a new Coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and SenSura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days
- •Have the mental capacity to understand the study and questionnaires
排除标准
- •Use irrigation during the study (flush the stoma with water).
- •Currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin)
- •Currently receiving or have within the last 2 months received chemotherapy or radiation therapy
- •Currently receive or have within the past three weeks been receiving steroid medication in the peristomal area.
- •Are pregnant or breastfeeding
结局指标
主要结局
Leakage (Percent of All Base Plates With Leakage)
时间窗: After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day
Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point
次要结局
- Adverse Events(During the investigation ~ 24 days per subject)
- Security (Subjects Own Assessment)(After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product)
- Handling at Appliance (Subjects Own Assessment)(After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product)
- Comfort (Subjects Own Assessment)(After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product)
- Wear Time (Registered by Subject When Applying and Removing a Product)(After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day)