Actively Recruiting
Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
Led by Salts Healthcare · Updated on 2024-12-18
27
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Adults aged over 18 years
- Have had a colostomy for 6 months or longer
- Experience filter-related complications (ballooning, pancaking, odour, or leakage) at least once a week
- Independent in managing colostomy care
- Using a flat, closed colostomy bag
- Have a stoma size less than 55 mm in diameter
- Use a colostomy bag with a hydrocolloid wafer (baseplate)
- Able to read and complete study questionnaires in English
You will not qualify if you...
- Use colostomy irrigation
- Have bleeding or broken skin around the stoma
- Have received radiotherapy or chemotherapy in the last 2 months
- Are pregnant or breastfeeding
- Are participating in another clinical study
- Are currently receiving treatment from a stoma clinical nurse specialist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Clinical Research Nurse
CONTACT
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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