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NCT06739174
Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication
Conditions: Colostomy - Stoma, Colostomy Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 27
Sponsor: Salts Healthcare
Location: Central Skin Sciences Institute (CSSI) Salts Healthcare Birmingham England
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT06739174). StuddyBuddy aggregates publicly available trial information.