An Exploratory Study Investigating Human Skin Reaction to Output
NCT ID: NCT02351791
Last Updated: 2023-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-02-28
2015-03-31
Brief Summary
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Detailed Description
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Patch 1: Standard adhesive with own feces
Patch 2: Standard adhesive with own feces mixture
Patch 3: Standard adhesive with simulated feces
Patch 4: Standard adhesive with simulated feces mixture
Patch 5: Standard adhesive with buffer (control)
Patch 6: Standard adhesive with buffer feces mixture (control)
Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.
A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Patch 1, 3 and 5
Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin
Measurements of skin at three locations of each patch: Center and under adhesive.
Patch 1
Patch 1:standard adhesive with own feces in sleeve
Patch 2
Patch 2:standard adhesive with own feces mixture in sleeve
Patch 3
Patch 3: standard adhesive with simulated feces in sleeve
Patch 4
Patch 4:standard adhesive with simulated feces mixture in sleeve
Patch 5
Patch 5:standard adhesive with buffer in sleeve
Patch 6
Patch 6:standard adhesive with buffer mixture in sleeve
Patch 2, 4 and 6
Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.
Patch 1
Patch 1:standard adhesive with own feces in sleeve
Patch 2
Patch 2:standard adhesive with own feces mixture in sleeve
Patch 3
Patch 3: standard adhesive with simulated feces in sleeve
Patch 4
Patch 4:standard adhesive with simulated feces mixture in sleeve
Patch 5
Patch 5:standard adhesive with buffer in sleeve
Patch 6
Patch 6:standard adhesive with buffer mixture in sleeve
Interventions
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Patch 1
Patch 1:standard adhesive with own feces in sleeve
Patch 2
Patch 2:standard adhesive with own feces mixture in sleeve
Patch 3
Patch 3: standard adhesive with simulated feces in sleeve
Patch 4
Patch 4:standard adhesive with simulated feces mixture in sleeve
Patch 5
Patch 5:standard adhesive with buffer in sleeve
Patch 6
Patch 6:standard adhesive with buffer mixture in sleeve
Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age and have full legal capacity
* Have had an ileostomy for more than one year
* Have normal to slightly red skin on the area used in the evaluation
* Has an ileostomy with a diameter up to (≤) 35 mm
* Have a peristomal area accessible for applied patches (assessed by investigator)
Exclusion Criteria
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
* Participating in other interventional clinical investigations or have previously participated in this investigation
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Lene F Nielsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Coloplast A/S
Locations
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Videncenter for Saarheling
Copenhagen NV, , Denmark
Countries
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Other Identifiers
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CP254
Identifier Type: -
Identifier Source: org_study_id
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