Three Way Crossover Study: Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication by People Living With a Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of ballooning
研究概览
简要总结
This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter
详细描述
The study will recruit participants living with a colostomy who experience complications related to colostomy bag filters. The study follows a repeated-measures design, in which each participant will test three types of colostomy bags (A, B, and C) over a 21-day period, divided into three 7-day test periods. During each test period, participants will use one type of colostomy bag for 7-days or up to 21 closed bags. Participants will be instructed to change the colostomy bag as often as they normally would or whenever they deem it necessary
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
- •Adult aged over 18 years
- •Colostomy for 6 months or longer
- •Experiences any filter-related complications, such as ballooning, pancaking, odour, or faecal leakage through the filter, at least once a week (7 days)
- •Independent in colostomy care
- •Using a flat, closed colostomy bag
- •Stoma size (diameter) less than 55 mm
- •Using a colostomy bag with a hydrocolloid wafer (baseplate)
- •Able to read and complete the study questionnaire in English
排除标准
- •Uses colostomy irrigation
- •Bleeding or broken peristomal skin
- •Receiving or had radiotherapy or chemotherapy in the last 2 months
- •Pregnant or breastfeeding
- •Taking part in another clinical study
- •Currently receiving treatment under the care of a stoma clinical nurse specialist
研究组 & 干预措施
Confidence Natural 1-Piece Closed Bag
The reference device is CE Marked and already commercially available
干预措施: Confidence Natural 1-Piece Closed Bag (Device)
Confidence Be 1-Piece Closed Bag
The reference device is CE Marked and already commercially available
干预措施: Confidence Be 1-Piece Closed Bag (Device)
Confidence Be go 1-Piece Closed Bag
The reference device is CE Marked and already commercially available in Australia
干预措施: Confidence Be go 1-Piece Closed Bag (Device)
结局指标
主要结局
Incidence of ballooning
时间窗: 21-days
Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter
次要结局
- Time of ballooning incidence(21-days)
- Wear time until ballooning incidence(21-days)
- Incidence of pancaking(21-days)
- Time of pancaking incidence(21-days)
- Wear time until pancaking incidence(21-days)
- Faecal leakage occurrence through the filter(21-days)
- Occurrence of odour through the filter(21-days)