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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
OCT scan and skin measurements of peristomal and abdominal skin
Bispebjerg Hospital, Department of dermatology and venerology
Copenhagen, Denmark
Thickness of the epidermal layer (assessed by OCT)
Scan of the peristomal skin
Time frame: immediately after the OCT scan
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