Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSalts Healthcare
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Uses colostomy irrigation
Bleeding or broken peristomal skin
Receiving or had radiotherapy or chemotherapy in the last 2 months
Pregnant or breastfeeding
Trial design
Treatments tested in this trial
- Confidence Be 1-Piece Closed Bag
- Confidence Natural 1-Piece Closed Bag
- Confidence Be go 1-Piece Closed Bag
Treatment groups
27 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov