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An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.
The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period .The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT)
12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. Subjects will use their standard of care ostomy device as intended and remove the device at the test visit.
The investigation consists of 2 visits, a screening visit (V0) and a Baseline/test visit (V1). V1 will also terminate the study period when the OCT scan and other skin measurements has been completed. The total study duration will be extended to a maximum of approximately 1 week, depending on the interval between V0 and V1.
The OCT scans and other skin measurements (TEWL, Hydration and Erythema measurements) will be performed on the skin when the ostomy device has been removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT scan + skin measurements abdominal and peristomal skin | Other | OCT scan + skin measurements abdominal and peristomal skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flat 1-piece open ostomy device | Device | OCT scan and skin measurements of peristomal and abdominal skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thickness of the epidermal layer (assessed by OCT) | Scan of the peristomal skin | immediately after the OCT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital, Department of dermatology and venerology | Copenhagen | 2400 | Denmark |
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