This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
35
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.
SGS proderm GmbH
Schenefeld, Free and Hanseatic City of Hamburg, Germany
RECRUITINGEvaluate 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 (%)
Time frame: From enrollment to end of follow-up at day 14.
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