Evaluating colostomy bags with an active filter system
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
This study is testing if colostomy bags with a special filter can help people avoid problems like ballooning and leaks better than regular bags.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Salts Healthcare Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Birmingham, England) |
| Trial ID | NCT06739174 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of colostomy bags equipped with an active chamber filter system in reducing complications such as ballooning and pancaking. Participants will use three different types of colostomy bags over a 21-day period, with each bag type tested for one week. The study aims to determine if the active filter system can minimize odour and faecal leakage compared to traditional colostomy bags. Participants will be instructed to change the bags as needed, reflecting their usual care routine.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a colostomy for at least 6 months who experience weekly filter-related complications.
Not a fit: Patients who use colostomy irrigation or have recent treatment for cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients with colostomies by reducing filter-related complications.
How similar studies have performed: While there have been studies on colostomy bag designs, this specific approach with an active filter system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, England
- Central Skin Sciences Institute (CSSI) Salts Healthcare — Birmingham, England, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mireille Hamson — Salt Healthcare
- Study coordinator: Clinical Research Coordinator
- Email: info@cssinstitute.co.uk
- Phone: +44 (0) 121 333 2015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.