Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06739174

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Central Skin Sciences Institute (CSSI) Salts Healthcare

Birmingham, England, United Kingdom, B7 4AA

Actively Recruiting

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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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