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The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensura | Active Comparator | Ostomy pouch |
|
| Flexima Active | Experimental | Ostomy pouch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexima Active | Device |
| ||
| Sensura |
| Measure | Description | Time Frame |
|---|---|---|
| Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura. | The patient will evaluate the level of leakage under the skin protector after each removal of pouch. A 4 scale level will be used:
| Up to one day for closed pouches and up to two days for drainable pouches. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the condition of peristomal skin | At V1 and V2 protocol visits (at day 0 and day 14) | |
| Acceptability of each pouch | Acceptability is defined by those criteria: Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bichat Hospital | Paris | France |
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| At each protocol visit (day 0, day 14 and day 28) |
| Preference between Flexima® Active and Sensura® | At each protocol visits (at day 0, day 14 and day 28) |
| Assessment of the quality of life with Stoma-QoL questionnaire | At each protocol visits (at day 0, day 14 and day 28) |
| Adverse(s) Event(s) | At each protocol visits (at day 0, day 14 and day 28) |