Clinical trial NCT06739174: Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colostomy - Stoma
Colostomy Complications
Keywords: Colostomy bags
Colostomy
Ballooning
Pancaking
Colostomy bag filter-related complications
Lead sponsor: Salts Healthcare
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ballooning
timeFrame: 21-days
Secondary outcomes:
measure: Time of ballooning incidence
timeFrame: 21-days
measure: Wear time until ballooning incidence
timeFrame: 21-days
measure: Incidence of pancaking
timeFrame: 21-days
measure: Time of pancaking incidence
timeFrame: 21-days
measure: Wear time until pancaking incidence
timeFrame: 21-days
measure: Faecal leakage occurrence through the filter
timeFrame: 21-days
measure: Occurrence of odour through the filter
timeFrame: 21-days
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Central Skin Sciences Institute (CSSI) Salts Healthcare
state: England
Study officials:
affiliation: Salt Healthcare
name: Mireille Hamson
role: PRINCIPAL_INVESTIGATOR
References: