An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Product Acceptance
研究概览
简要总结
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
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 letter of authority
- •Be at least 18 years of age and have full legal capacity
- •Be able to handle the products her/himself
- •Have an ileostomy with a diameter between 10 and 30 mm
- •Willing to follow the product change schedule (one change per day)
- •Have had their ostomy for at least three months
- •Willing to use 1 piece open ostomy products during the test period
- •Must be able to use a custom cut product
- •Have intact skin
- •Negative result of a pregnancy test for women of childbearing age
排除标准
- •Currently receiving or have within the past 2 months 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
- •Is pregnant or breastfeeding.
- •Is participating in other interventional clinical investigations or have previously participated in this investigation
- •Have a loop ileostomy
- •Known hypersensitivity towards any of the test products
结局指标
主要结局
Product Acceptance
时间窗: 7 days per test period
Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product
次要结局
未报告次要终点