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

Salts Healthcare

Status: Enrolling

Conditions: Colostomy - Stoma; Colostomy Complications

Treatments: Device: Confidence Be 1-Piece Closed Bag; Device: Confidence Be go 1-Piece Closed Bag; Device: Confidence Natural 1-Piece Closed Bag

Study type: Interventional

Funder types: Industry

Identifiers

NCT06739174

24/EE/0241

Details and patient eligibility

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

Full 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

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Confidence Be 1-Piece Closed Bag

Active Comparator group

Description:

The reference device is CE Marked and already commercially available

Treatment:

Device: Confidence Be 1-Piece Closed Bag

Confidence Natural 1-Piece Closed Bag

Active Comparator group

Description:

The reference device is CE Marked and already commercially available

Treatment:

Device: Confidence Natural 1-Piece Closed Bag

Confidence Be go 1-Piece Closed Bag

Active Comparator group

Description:

The reference device is CE Marked and already commercially available in Australia

Treatment:

Device: Confidence Be go 1-Piece Closed Bag