Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2025-04-07
2025-05-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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OCT scan + skin measurements abdominal and peristomal skin
OCT scan + skin measurements abdominal and peristomal skin
flat 1-piece open ostomy device
OCT scan and skin measurements of peristomal and abdominal skin
Interventions
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flat 1-piece open ostomy device
OCT scan and skin measurements of peristomal and abdominal skin
Eligibility Criteria
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Inclusion Criteria
2. Is at least 18 years old
3. Has full legal capacity
4. Has an ileostomy
5. Is using a flat 1-piece open ostomy device
6. Have had the ileostomy for a year
Exclusion Criteria
2. Is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet
3. Is pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Bispebjerg Hospital, Department of dermatology and venerology
Copenhagen, , Denmark
Countries
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Other Identifiers
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CP376
Identifier Type: -
Identifier Source: org_study_id
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