Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CareFusion
• Treatments: Anti-Infective Agents; Chlorhexidine; Chlorhexidine gluconate; Iodine; Povidone; Povidone-Iodine

Criteria

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