Infectious Disease Clinical Trial
Official title:
Pilot Clinical Trial - Comparative Study of Two Material Concentration of OD-141309 With Controls When Used as a Preoperative Skin Disinfection Preparation.
A sufficient number of subjects will be entered into testing to complete 42 subjects per each of the 2 test and 2 control configurations. A total of 84 subjects, testing bi-laterally (168 abdomen and groin sites in total completed, 42 abdomen and groin sites per each test and control material) will be evaluated using the standardized ASTM E1173 test method. Following a 14-day restriction period, subjects will be sampled for baseline, 10 minutes, 6 hours, and 24 hours post application (subjects will not be sequestered) for microbial reduction evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and groin: ≥ 5.0 log10 CFU/cm2.
At least 84 subjects will be treated bilaterally with two of the four test materials (Test Product #1, Test Product #2, Positive Control, and Negative Control), one per each side of the abdomen and inguinal test sites. Subjects will be required to complete a 14-day pretest conditioning period. Subjects will complete a 2-day test period, during which time subjects' sites will be treated with the test materials and samples taken following treatment. The Cylinder Sampling Technique will be performed for baseline and for sampling 10-minutes, 6-hours, and 24-hours post-test material-application on Test Days. The effectiveness criteria are that the log10 recoveries of the two test products (1% and 1.5%) are non-inferior to the Positive Control (2.0% chlorhexidine gluconate) with a 0.5 margin (log10 scale) per square centimeter on the abdominal and inguinal sites within 10 minutes after drying. The determination of non-inferiority will be based on the upper bounds of the 95% confidence interval being equal to or less than 0.5. Superiority will not be evaluated in this study. ;
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