NCT03154944已完成不适用
A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Trans Epidermal Water Loss
研究概览
简要总结
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 in DK: signed a letter of authority
- •Be at least 18 years of age and have full legal capacity
- •Have had their ileostomy for at least 3 months
- •Have an ileostomy with a diameter between 10 and 55 mm
- •Be able to handle the Clinical App. and product themselves
- •Must be able to use custom cut product
- •Minimum change of product every second day
- •If current product is SenSura Mio - Be willing to use Maxi bag during investigation
- •Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.
- •Negative result of a pregnancy test for women of childbearing age (only DK)
排除标准
- •Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
- •Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
- •Are pregnant or breastfeeding**
- •Are participating in other interventional clinical investigations or have previously participated in this investigation
- •Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
- •Have known hypersensitivity towards any of the products used in the investigation
结局指标
主要结局
Trans Epidermal Water Loss
时间窗: 7 days
The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).
次要结局
未报告次要终点
研究者
研究点 (2)
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