An Open-labelled, Randomised, Controlled, Crossover Investigation Evaluating Performance of a Newly Developed Ostomy Care Product Compared to Standard Care.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
研究概览
简要总结
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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.
- •Be at least 18 years of age and have full legal capacity.
- •Have experienced leakage under the base plate at least once a week over the last two weeks.
- •Be able to handle the bags themselves or with help from caregiver (e.g. spouse).
- •Have a colostomy with a diameter between 20 and 45 mm.
- •Have had their ostomy for at least three months.
- •Currently use a 1-piece flat product with closed bag.
- •Use minimum 1 product per day.
- •Be suitable for participation in the investigation and for using a standard adhesive, flat base plate (evaluated by investigator).
排除标准
- •Use irrigation during the study (flush the stoma with water).
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
- •Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
- •Are pregnant or breastfeeding.
- •Participating in other interventional clinical investigations or have previously participated in this investigation.
结局指标
主要结局
Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)
时间窗: 14 days
Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.
次要结局
未报告次要终点