Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 29
- 主要终点
- Degree of Leakage
研究概览
简要总结
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
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
- •Are at least 18 years of age and have full legal capacity.
- •Has had an ileostomy for at least 3 months.
- •Has used a convex ostomy product for the last month.
- •Has given signed informed consent.
- •Has experienced seeping under the baseplate at least three times during the last two weeks.
- •Currently using a SenSura Convex product with midi, maxi or magnum bags.
- •Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
- •Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.
排除标准
- •Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
- •Are pregnant or breastfeeding.
- •Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
- •Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
- •Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
- •Are currently participating in another clinical intervention study or have previously participated in this one.
- •Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
- •Has known hypersensitivity toward the test product.
研究组 & 干预措施
First Coloplast test product
The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light
干预措施: Coloplast test product (Device)
First Coloplast test product
The subjects test:
test period 1: Coloplast test product test period 2: SenSura Convex Light
干预措施: SenSura Convex Light (Device)
First SenSura Convex Light
The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product
干预措施: Coloplast test product (Device)
First SenSura Convex Light
The subjects test:
test period 1: SenSura Convex Light test period 2: Coloplast test product
干预措施: SenSura Convex Light (Device)
结局指标
主要结局
Degree of Leakage
时间窗: 28 +/- 3 days
The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
次要结局
未报告次要终点