RecruitingNot ApplicableNCT06739174

Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication

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


Sponsor

Salts Healthcare

Enrollment

27 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria6

  • 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

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Interventions

DEVICEConfidence Be 1-Piece Closed Bag

Active Chamber Filter - Circle Shape

DEVICEConfidence Natural 1-Piece Closed Bag

Protective Filter - Circle Shape

DEVICEConfidence Be go 1-Piece Closed Bag

Active Chamber Filter - Hexagon Shape


Locations(1)

Central Skin Sciences Institute (CSSI) Salts Healthcare

Birmingham, England, United Kingdom

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NCT06739174


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