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NCT Number: NCT06739174

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

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

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Key information

Conditions

Colostomy - Stoma Colostomy Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Skin Sciences Institute (CSSI) Salts Healthcare

Birmingham, England, B7 4AA, United Kingdom

Location status: Recruiting

Location contact

Mireille Hamson

PRINCIPAL_INVESTIGATOR

About this study

The study will recruit participants living with a colostomy who experience complications related to colostomy bag filters. The study follows a repeated-measures design, in which each participant will test three types of colostomy bags (A, B, and C) over a 21-day period, divided into three 7-day test periods. During each test period, participants will use one type of colostomy bag for 7-days or up to 21 closed bags. Participants will be instructed to change the colostomy bag as often as they normally would or whenever they deem it necessary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Confidence Be 1-Piece Closed Bag

Device

Active Chamber Filter - Circle Shape

Confidence Natural 1-Piece Closed Bag

Device

Protective Filter - Circle Shape

Confidence Be go 1-Piece Closed Bag

Device

Active Chamber Filter - Hexagon Shape

Primary outcomes

  1. Incidence of ballooning

    Time frame: 21-days

    Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter

Secondary outcomes

  1. Time of ballooning incidence

    Time frame: 21-days

    Evaluation and comparison of the timing of ballooning over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter

  2. Wear time until ballooning incidence

    Time frame: 21-days

    Evaluation and comparison of the wear time duration of colostomy bags with an active chamber filter system and a protective filter until a ballooning incident occurs

  3. Incidence of pancaking

    Time frame: 21-days

    Evaluation and comparison of the incidence of pancaking in colostomy bags with an active chamber filter system and a protective filter

  4. Time of pancaking incidence

    Time frame: 21-days

    Evaluation and comparison of the timing of pancaking incidents over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter

  5. Wear time until pancaking incidence

    Time frame: 21-days

    Evaluation and comparison of the wear time duration of colostomy bags with active chamber filter system and a protective filter until pancaking incident to occur

  6. Faecal leakage occurrence through the filter

    Time frame: 21-days

    Evaluation and comparison of faecal leakage occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter

  7. Occurrence of odour through the filter

    Time frame: 21-days

    Evaluation and comparison of odour occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research

CONTACT

Samantha Jarvis Clinical Research Coordinator

CONTACT

[email protected]

+44 (0) 121 333 2015

Sponsors and collaborators

Lead sponsor

Salts Healthcare

Industry

Registry information

Official study title

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

Acronym: BREEZE-01

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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