This is a 7 day primary irritation patch test. This study investigates the irritation potential of Next Science MIS Wound Irrigation Solution under standardized conditions compared with an inert control (normal saline) and a known irritant, 20% sodium dodecyl sulfate (also known as sodium lauryl sulfate \[SLS\]) solution in deionized water \[DI\] water) on intact skin of healthy human subjects.
In accordance with ISO 10993-10:2010(E), study products will be delivered via dermal patch at 15 and 30 minutes (min) and up to 1-hour (h), 2-h, 3-h, 4-h and then, pending results, 24-h (evaluated up to at least 48-h) continuous exposure. Response rate will be evaluated immediately after application then 1 h, 2 h, 24 h, 48 h, and then 72 h post-exposure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
33
This will be administered via skin patch.
This will be administered via skin patch.
This will be administered via skin patch.
To evaluate the effects of wound solution on healthy volunteers when applied to the skin.
Response Grade of Irritation
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.