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

NCT06739174 | Recruiting

• 1 other identifier: 24/EE/0241
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colostomy - Stoma; Colostomy Complications

Keywords

Colostomy bags; Colostomy; Ballooning; Pancaking; Colostomy bag filter-related complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time of ballooning incidence

  21-days

• Wear time until ballooning incidence

  21-days

• Incidence of pancaking

  21-days

• Time of pancaking incidence

  21-days

• Wear time until pancaking incidence

  21-days

Study Arms (3)

Confidence Be 1-Piece Closed Bag

ACTIVE COMPARATOR

The reference device is CE Marked and already commercially available

Device: Confidence Be 1-Piece Closed Bag

Confidence Natural 1-Piece Closed Bag

ACTIVE COMPARATOR

The reference device is CE Marked and already commercially available

Device: Confidence Natural 1-Piece Closed Bag

Confidence Be go 1-Piece Closed Bag

ACTIVE COMPARATOR

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

Device: Confidence Be go 1-Piece Closed Bag

Interventions

Confidence Be 1-Piece Closed Bag DEVICE

Active Chamber Filter - Circle Shape

Confidence Be 1-Piece Closed Bag

Confidence Natural 1-Piece Closed Bag DEVICE

Protective Filter - Circle Shape

Confidence Natural 1-Piece Closed Bag

Confidence Be go 1-Piece Closed Bag DEVICE

Active Chamber Filter - Hexagon Shape

Confidence Be go 1-Piece Closed Bag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salts Healthcare: lead

Study Sites (1)

Central Skin Sciences Institute (CSSI) Salts Healthcare

Birmingham, England, B7 4AA, United Kingdom

RECRUITING

Study Officials

• Mireille Hamson

  Salt Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

+44 (0) 121 333 2015; info@cssinstitute.co.uk

Clinical Research Nurse

CONTACT

07917630767; sarah.ashworth@salts.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: November 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)