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To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexima 3S | Active Comparator | Flexima 3S is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) |
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| New 2-piece ostomy appliance | Experimental | New 2-piece appliance is a 2-piece ostomy appliance composed with an adhesive base plate and a drainable pouch for collecting stools (1 base plate for 5 days and 1 pouch for 5 days) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexima 3S | Device | Flexima 3S (2-piece appliance) with drainable pouch |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period | For each base plate, the wear time will be evaluated during 21 (±3) days | On average every 5 days, up to 21 (±3) days for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the condition of peristomal skin | Using a standardized measuring ostomy skin tool | After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days) |
| Assessment of the main reason of base plate removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aude Michaud | Contact | +33632542788 | aude.michaud@bbraun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Selayang | Recruiting | Batu Caves | 68100 | Malaysia |
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| New 2-piece ostomy appliance | Device | New 2-piece ostomy appliance with drainable pouch |
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After each base plate removal, the patient will describe on a 7-point scale the main reason of base plate removal ("habit", "hygiene", "leakage under the base plate", "unsticking of the base plate periphery", "unsticking of the base plate, not only on the periphery", "ask for the study but the base plate could stay longer in place", "other, to specify". No value is considered as the better outcome, it's only descriptive value.
| From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period |
| Assessment of acceptability | At the end of each study period (21 (±3) days), the patient will assess on a 4-point scale each parameter of acceptability ("very good", "good", "bad", "very bad". The "very good" value is considered as the better outcome. | At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days) |
| Assessment of use of accessories | After each base plate removal, the patient will describe on a 8-point scale the use of accessories ("none", "protective spray", "powder", "paste", "ring", "adhesive remover", "belt", "other, to specify". No value is considered as the better outcome, it's only descriptive value. | From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period |
| Preference between Flexima® 3S and the new 2-piece ostomy appliance | At the end of the study, the patient will notify the preference between Flexima® 3S and the new 2-piece appliance | At the end of the study, at 42 (±6) days |
| Safety: Adverse(s) Event(s) | Description of all adverse event related or not to the devices studied | From date of randomization until the date of first adverse event, assessed up to 42 (±6) days |
| Hospital Canselor Tuanku Muhriz | Recruiting | Kuala Lumpur | 56000 | Malaysia |
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