Assessment of New Enhanced Ostomy Devices in Real-life Set-tings in Subjects Having an Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Trans epidermal water loss
研究概览
简要总结
The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
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 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
- •Must be able to use custom cut product
- •Can use a product with max cut size 45 mm
- •Self-reported problems with leakage (3 x within 14 days)
- •Get a 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 4.
- •Exception: Participation in other Coloplast in-house clinical investigations are 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 (CP264) protocol.
- •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
研究组 & 干预措施
Arm 1
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
干预措施: SenSura Mio (Device)
Arm 1
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
干预措施: Coloplast Ostomy device 1 (Device)
Arm 1
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
干预措施: Coloplast Ostomy device (Device)
Arm 1
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3
干预措施: Coloplast Ostomy device 3 (Device)
Arm 2
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
干预措施: SenSura Mio (Device)
Arm 2
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
干预措施: Coloplast Ostomy device 1 (Device)
Arm 2
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
干预措施: Coloplast Ostomy device (Device)
Arm 2
The subjects test the products in the following order
SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2
干预措施: Coloplast Ostomy device 3 (Device)
结局指标
主要结局
Trans epidermal water loss
时间窗: 14 days
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 aloss 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
次要结局
未报告次要终点