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The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 2 Coloplast Ostomy device 3 |
|
| Arm 2 | Experimental | The subjects test the products in the following order SenSura Mio (comparator) Coloplast Ostomy device 1 Coloplast Ostomy device 3 Coloplast Ostomy device2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura Mio | Device | SenSura Mio is a marked ostomy device which is used as the comparator in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trans epidermal water loss | Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte P Jakobsen, MD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark | |||
| CCBR Vejle |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 1, 2020 | |
| Reset | Sep 24, 2020 | |
| Release | Sep 29, 2023 | |
| Reset | Mar 29, 2024 | |
| Release | Mar 7, 2025 | |
| Reset | Mar 26, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 1, 2020 | Sep 24, 2020 | |||
| Sep 29, 2023 |
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| Coloplast Ostomy device 1 | Device | Coloplast Ostomy device 1 a newly developed ostomy device |
|
| Coloplast Ostomy device | Device | Coloplast Ostomy device 2 a newly developed ostomy device |
|
| Coloplast Ostomy device 3 | Device | Coloplast Ostomy device 3 a newly developed ostomy device |
|
| Vejle |
| 7100 |
| Denmark |
| QPS Netherlands | Groningen | 9713 | Netherlands |
| Mar 29, 2024 |
| Mar 7, 2025 | Mar 26, 2025 |