Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
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
Salts Healthcare
27 participants
Nov 29, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria6
- 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
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Interventions
Active Chamber Filter - Circle Shape
Protective Filter - Circle Shape
Active Chamber Filter - Hexagon Shape
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06739174