Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint

060629

Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.

2007-10-01

2008-02-01

2008-02-01

Completed

Early phase I

122

Inclusion Criteria: * Free of dermatoses, cuts, lesions, or other skin disorders around test sites * must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and agree to abstain from these materials until completion of the study Exclusion Criteria: * Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 7 day pre-test period or during the test period * exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period * use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period * known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine * active skin rashes or breaks in the skin of the test sites * currently active skin disease or inflammatory skin condition, including contact dermatitis * showering or bathing within the 72 hour period prior to sampling * participation in a clinical study in the past 7 days or current participation in another clinical study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 122, 'type': 'ACTUAL'}}

2023-07-12