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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Confidence Be 1-Piece Closed Bag | Active Comparator | The reference device is CE Marked and already commercially available |
|
| Confidence Natural 1-Piece Closed Bag | Active Comparator | The reference device is CE Marked and already commercially available |
|
| Confidence Be go 1-Piece Closed Bag | Active Comparator | The reference device is CE Marked and already commercially available in Australia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confidence Be 1-Piece Closed Bag | Device | Active Chamber Filter - Circle Shape |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | +44 (0) 121 333 2015 | info@cssinstitute.co.uk | |
| Clinical Research Nurse | Contact | 07917630767 | sarah.ashworth@salts.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mireille Hamson | Salt Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Skin Sciences Institute (CSSI) Salts Healthcare | Recruiting | Birmingham | England | B7 4AA | United Kingdom |
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| Confidence Natural 1-Piece Closed Bag | Device | Protective Filter - Circle Shape |
|
| Confidence Be go 1-Piece Closed Bag | Device | Active Chamber Filter - Hexagon Shape |
|
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 |