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About
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.
Full description
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.
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Individuals eligible for inclusion in the study were those who:
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33 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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