A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Leakage Under the Base Plate
研究概览
简要总结
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.
详细描述
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems.
The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market.
The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home.
80 healthy participants with an ileostomy will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Have given written Informed Consent
- •Are at least 18 years old
- •Had their ileostomy for minimum 3 months with a size between 20-40 mm
- •Have mental capacity to understand study guidelines and questionnaires
- •Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
- •Experience leakage under the base plate at least one a week
- •Are currently using a flat 2-piece base plate with mechanical coupling
- •Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study
排除标准
- •Pregnant or breast-feeding
- •Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
- •Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- •Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
- •Currently using a convex system
- •Participating in other clinical studies or have previously participated in this study
研究组 & 干预措施
New ostomy appliance (Atlas)
Atlas= new base plate. Due to company confidentiality the product is just called Atlas and this is not short for any other names
干预措施: Atlas (Device)
SenSura
Commercially available ostomy appliance
干预措施: SenSura (Device)
Conform 2
Commercially available ostomy appliance
干预措施: Conform 2 (Device)
结局指标
主要结局
Leakage Under the Base Plate
时间窗: At every change of base plate
Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.
次要结局
未报告次要终点