Colostomy Complications, Colostomy - Stoma
Conditions
Keywords
Colostomy bags, Colostomy, Ballooning, Pancaking, Colostomy bag filter-related complications
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
Interventions
DEVICEConfidence Be 1-Piece Closed Bag
Active Chamber Filter - Circle Shape
DEVICEConfidence Natural 1-Piece Closed Bag
Protective Filter - Circle Shape
DEVICEConfidence Be go 1-Piece Closed Bag
Active Chamber Filter - Hexagon Shape
Sponsors
Salts Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ballooning | 21-days | Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of ballooning incidence | 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 |
| Wear time until ballooning incidence | 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 |
| Incidence of pancaking | 21-days | Evaluation and comparison of the incidence of pancaking in colostomy bags with an active chamber filter system and a protective filter |
| Time of pancaking incidence | 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 |
| Wear time until pancaking incidence | 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 |
| Faecal leakage occurrence through the filter | 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 |
| Occurrence of odour through the filter | 21-days | Evaluation and comparison of odour occurrence through the filter in colostomy bags with an active chamber filter system and a protective filter |
Countries
United Kingdom
Contacts
CONTACTSamantha Jarvis Clinical Research Coordinator
CONTACTClinical Research
PRINCIPAL_INVESTIGATORMireille Hamson
Salt Healthcare
Outcome results
None listed