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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
27
Active Chamber Filter - Circle Shape
Protective Filter - Circle Shape
Active Chamber Filter - Hexagon Shape
Central Skin Sciences Institute (CSSI) Salts Healthcare
Birmingham, England, United Kingdom
RECRUITINGIncidence of ballooning
Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter
Time frame: 21-days
Time of ballooning incidence
Evaluation and comparison of the timing of ballooning over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter
Time frame: 21-days
Wear time until ballooning incidence
Evaluation and comparison of the wear time duration of colostomy bags with an active chamber filter system and a protective filter until a ballooning incident occurs
Time frame: 21-days
Incidence of pancaking
Evaluation and comparison of the incidence of pancaking in colostomy bags with an active chamber filter system and a protective filter
Time frame: 21-days
Time of pancaking incidence
Evaluation and comparison of the timing of pancaking incidents over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter
Time frame: 21-days
Wear time until pancaking incidence
Evaluation and comparison of the wear time duration of colostomy bags with active chamber filter system and a protective filter until pancaking incident to occur
Time frame: 21-days
Faecal leakage occurrence through the filter
Evaluation and comparison of faecal leakage occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter
Clinical Research
CONTACT
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Time frame: 21-days
Occurrence of odour through the filter
Evaluation and comparison of odour occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter
Time frame: 21-days