Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication (BREEZE-01)

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

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

Study Overview

• Status: Recruiting
• Conditions: Colostomy - Stoma; Colostomy Complications
• Intervention / Treatment: Device: Confidence Be 1-Piece Closed Bag; Device: Confidence Natural 1-Piece Closed Bag; Device: Confidence Be go 1-Piece Closed Bag

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: +44 (0) 121 333 2015; Email: info@cssinstitute.co.uk
• Study Contact Backup: Name: Clinical Research Nurse; Phone Number: 07917630767; Email: sarah.ashworth@salts.co.uk

Study Locations

• United Kingdom
  • England
    • Birmingham, England, United Kingdom, B7 4AA
      • Recruiting
      • Central Skin Sciences Institute (CSSI) Salts Healthcare
      • Contact: Mireille Hamson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Confidence Be 1-Piece Closed Bag; The reference device is CE Marked and already commercially available	Device: Confidence Be 1-Piece Closed Bag; Active Chamber Filter - Circle Shape
Active Comparator: Confidence Natural 1-Piece Closed Bag; The reference device is CE Marked and already commercially available	Device: Confidence Natural 1-Piece Closed Bag; Protective Filter - Circle Shape
Active Comparator: Confidence Be go 1-Piece Closed Bag; The reference device is CE Marked and already commercially available in Australia	Device: Confidence Be go 1-Piece Closed Bag; Active Chamber Filter - Hexagon Shape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ballooning	Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter	21-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of ballooning incidence	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	21-days
Wear time until ballooning incidence	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	21-days
Incidence of pancaking	Evaluation and comparison of the incidence of pancaking in colostomy bags with an active chamber filter system and a protective filter	21-days
Time of pancaking incidence	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	21-days
Wear time until pancaking incidence	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	21-days
Faecal leakage occurrence through the filter	Evaluation and comparison of faecal leakage occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter	21-days
Occurrence of odour through the filter	Evaluation and comparison of odour occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter	21-days

Collaborators and Investigators

• Sponsor: Salts Healthcare
• Investigators: Principal Investigator: Mireille Hamson, Salt Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Colostomy; Ballooning; Colostomy bags; Pancaking; Colostomy bag filter-related complications
• Other Study ID Numbers: 24/EE/0241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No