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This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 dressings applied to designated sites on healthy volunteer participants | Other | The investigation will evaluate the dressing and the application regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dressing | Device | The dressing will be applied to intact skin on healthy volunteers participants to assess the self-adhesive properties of two investigational devices compared to a test specimen reference. The dressing will be worn for up to 14 days on a designated area on the health volunteers participants back. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate stay-on-ability of the test specimens compared to the test specimen reference | The percentage detachment of each test specimen and the test specimen reference will be assessed using a counting grid method. A standardized grid-patterned template will be applied to the application area to objectively quantify the area of detachment. The result will be expressed as a percentage of the total surface area in terms of the mean % detachment at Day 14. Unit of Measure: Percentage (%) | From enrollment to end of follow-up at day 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Welinder | Contact | +46 (0)31- 722 31 96 | kristina.welinder@molnlycke.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Uta Solecke | SGS proderm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Recruiting | Schenefeld | Free and Hanseatic City of Hamburg | 22869 | Germany |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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