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Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication

RecruitingNAAges 18 Years - anyAllSalts Healthcare
NCT06739174 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Confidence Be 1-Piece Closed Bag
  • Confidence Natural 1-Piece Closed Bag
  • Confidence Be go 1-Piece Closed Bag
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Where

1 site
Central Skin Sciences Institute (CSSI) Salts Healthcare
Birmingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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