An Exploratory Study Investigating Human Skin Reaction to Output

Study Overview
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Brief Summary
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The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Detailed Description
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Six types of patches are tested: 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

Official Title
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An Exploratory Study Investigating Human Skin Reaction to Output

Conditions
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Ileostomy

Intervention / Treatment
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* Other: Patch 1
* Other: Patch 2
* Other: Patch 3
* Other: Patch 4
* Other: Patch 5
* Other: Patch 6


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent 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 2 months received radio- and/or chemotherapy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patch 1, 3 and 5<br>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. | Other: Patch 1<br>* Patch 1:standard adhesive with own feces in sleeve<br>Other: Patch 2<br>* Patch 2:standard adhesive with own feces mixture in sleeve<br>Other: Patch 3<br>* Patch 3: standard adhesive with simulated feces in sleeve<br>Other: Patch 4<br>* Patch 4:standard adhesive with simulated feces mixture in sleeve<br>Other: Patch 5<br>* Patch 5:standard adhesive with buffer in sleeve<br>Other: Patch 6<br>* Patch 6:standard adhesive with buffer mixture in sleeve<br>|
| Experimental: Patch 2, 4 and 6<br>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. | Other: Patch 1<br>* Patch 1:standard adhesive with own feces in sleeve<br>Other: Patch 2<br>* Patch 2:standard adhesive with own feces mixture in sleeve<br>Other: Patch 3<br>* Patch 3: standard adhesive with simulated feces in sleeve<br>Other: Patch 4<br>* Patch 4:standard adhesive with simulated feces mixture in sleeve<br>Other: Patch 5<br>* Patch 5:standard adhesive with buffer in sleeve<br>Other: Patch 6<br>* Patch 6:standard adhesive with buffer mixture in sleeve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans Epidermal Water Loss After Test of Patches. | Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive). | Approximately 7-10 hours |