The adhesion of the new adhesive strips is investigated on healthy volunteers
Inclusion visit: * Introduction to the study * Inclusion in study * Baseline information is obtained * Instruct subject to pre-strip of abdominal skin Test visits 1-25 (up to maximum 25 visits per subject. (1-3 days after pre-stripping the abdominal skin): * Baseline measurements are conducted on both sides of the stomach (TEWL, hydration, erythema, pH - 3 repeated measurements under each adhesive strip area (upper, middle and bottom of adhesive strip) * Potential wetting of skin - shower/bicycle exercise (max 60 minutes) and after-wetting baseline measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Adhesive strips are weighted and applied * Potential shower/bicycle exercise (max 60 minutes) * Adhesive strips are removed at pre-defined timeslots (peel force measured) * Discomfort when strip was peeled of is evaluated by subject (VAS) * Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Acclimatization ½ * Measurements are conducted (TEWL, hydration, erythema, pH - 3 times/strips (upper, middle and bottom of adhesive strip)) * Adhesive strips are weighed * Photo of adhesive strips The subjects can be asked to apply and change strips every 24 hours between two test visits but for a maximum of 10 days between two visits. The strips should be applied at the same place every time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
This strip contains a standard hydrocolloid adhesive found in ostomy devices
This strip contains a standard hydrocolloid adhesive found in ostomy devices
This strip contains a new adhesive
Coloplast A/S
Humlebæk, Denmark
Swelling of the adhesive
Swelling of adhesive strips measured by weight (difference between the weight of the strip before and after use)
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
This strip contains a new adhesive