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The objective is to investigate the impact that faecal output has on adhesives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patch 3/Patch4 + Patch1/patch2 + patch 5/patch 6 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 3 and Patch 4 Test period 2: Patch 1 and Patch 2 Test period 3: Patch 5 and Patch 6 |
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| Patch 1/Patch2 + Patch3/patch4 + patch 5/patch 6 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 |
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| Patch 1/Patch2 + Patch5/patch 6 + patch 3/patch 4 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patch 1 | Other | Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip |
| Measure | Description | Time Frame |
|---|---|---|
| Remaining adherent area of the adhesive | The remaining adherent area of the adhesive strips is assessed by measuring the difference in total area of output and swelling. | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte P Jakobsen, MD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Term |
|---|---|
| C000595790 | Sugp2 protein, mouse |
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| Patch 3/Patch4 + Patch5/patch6 + patch 3/patch 4 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 3 and Patch 4 Test period 2: Patch 5 and Patch 6 Test period 3: Patch 1 and Patch 2 |
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| Patch 5/Patch 6 + Patch 3/patch 4 + patch 1/patch 2 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 5 and Patch 6 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 1 and Patch 2 |
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| Patch 5/Patch 6 + Patch1/patch2 + patch 3/patch 4 | Experimental | The subjects test 6 adhesive strips; two in each test period. The patches are tested in pairs i.e Patch 1 and patch 2 are a pair; Patch 3 and Patch 4 are a piar and patch 5 and patch 6 are a pair. The test order of the patch pairs is randomised between the three periods. In this arm the the subjects test: Test period 1: Patch 1 and Patch 2 Test period 2: Patch 3 and Patch 4 Test period 3: Patch 5 and Patch 6 |
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| Patch 2 | Other | Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip |
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| Patch 3 | Other | Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip |
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| Patch 4 | Other | Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip |
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| patch 5 | Other | Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip |
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| Patch 6 | Other | Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip |
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