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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Central Skin Sciences Institute (CSSI) Salts Healthcare
RECRUITING
Birmingham
Contact Information
Primary
Clinical Research Coordinator
info@cssinstitute.co.uk
+44 (0) 121 333 2015
Backup
Clinical Research Nurse
sarah.ashworth@salts.co.uk
07917630767
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 27
Treatments
Active_comparator: Confidence Be 1-Piece Closed Bag
The reference device is CE Marked and already commercially available
Active_comparator: Confidence Natural 1-Piece Closed Bag
The reference device is CE Marked and already commercially available
Active_comparator: Confidence Be go 1-Piece Closed Bag
The reference device is CE Marked and already commercially available in Australia
Related Therapeutic Areas
Sponsors
Leads: Salts Healthcare

This content was sourced from clinicaltrials.gov