Actively Recruiting
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
Led by Salts Healthcare · Updated on 2024-12-18
27
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating colostomy bags with an active chamber filter system to see if they reduce filter-related problems such as ballooning, pancaking, odor, and fecal leakage compared to bags with a protective filter. The study focuses on adults living with a colostomy who experience these complications frequently. It is designed as a three-way crossover study, allowing each participant to try different types of colostomy bags. Participants will use three types of colostomy bags—Confidence Be 1-Piece Closed Bag with an active chamber filter (circle shape), Confidence Natural 1-Piece Closed Bag with a protective filter (circle shape), and Confidence Be go 1-Piece Closed Bag with an active chamber filter (hexagon shape). Each bag will be used for a 7-day period or up to 21 closed bags, with participants changing bags as they normally would or when necessary. The study lasts 21 days in total, divided into three 7-day test periods. During the study, participants will report on filter-related complications such as ballooning, pancaking, odor, and fecal leakage through the filter. Researchers will monitor the incidence and timing of these issues over the 21-day period. Participants will complete questionnaires in English about their experiences, and their independent colostomy care will be supported throughout. The study aims to measure the effectiveness of the active chamber filter system in reducing common colostomy bag problems.
CONDITIONS
Brief Title
Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 21 days
Participants will test three types of colostomy bags over three 7-day test periods, using each type for 7 days or up to 21 closed bags. Participants will change the colostomy bag as often as they normally would or whenever necessary.
3 consecutive 7-day test periods
Trial Site Locations
Total: 1 location
1
Central Skin Sciences Institute (CSSI) Salts Healthcare
Birmingham, England, United Kingdom, B7 4AA
Actively Recruiting
Research Team
C
Clinical Research Coordinator
C
Clinical Research Nurse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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