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The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test of a new adhesive strip | Experimental | This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 24 hours. The adhesive strip is not yet part of a marketed ostomy device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New adhesive strip | Other | This is a newly developed strip. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trans epidermal water loss | The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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