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The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 01a | Experimental | This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buffer | Other | The sleeve contains phosphate buffered saline buffer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Remaining adhesive area of adhesive | The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area. | 30 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene F Nielsen, MSc | R&D Principal Scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Term |
|---|---|
| D002021 | Buffers |
| ID | Term |
|---|---|
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Own output |
| Other |
The sleeve contains the subject own ileal effluent |
|
| simulated output | Other | The sleeve contains simulated output |
|