NCT03770078已完成不适用
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Trans Epidermal Water Loss
研究概览
简要总结
The study investigates the performance of a new adhesive with regard to the skin condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Have an ileostomy or a colostomy with liquid* output (as their usual output)
- •Be at least 18 years of age and have full legal capacity
- •Have had their stoma for at least three months
- •Be able to use products with max cut size 45 mm
- •Have self-reported problems with leakage** (three times within 14 days)
- •Handle the Clinical App, test product and comparator product themselves
- •Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
- •Minimum change of baseplate at least once every 3rd day
- •Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
- •Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation
排除标准
- •Are currently receiving or have within the past two 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) or systemic treatment* (e.g. injection or tablets).
- •Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
- •Are breast feeding
- •Are participating in other interventional clinical investigations or have previously participated in this investigation
- •Participation in other Coloplast in-house 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 (CP300) protocol.
- •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: Four weeks
Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage. Trans Epidermal Water Loss is reported 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 (8)
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