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

C. R. Bard1 site in 1 country122 target enrollmentOctober 1, 2007

ConditionsHealthy

InterventionsChlorhexidine gluconate Povidone iodine

DrugsChlorhexidine gluconate Povidone iodine

Overview

Phase: Phase 3
Intervention: Chlorhexidine gluconate
Conditions: Healthy
Sponsor: C. R. Bard
Enrollment: 122
Locations: 1
Primary Endpoint: 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA. Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.

Registry

clinicaltrials.gov

Start Date

October 1, 2007

End Date

February 1, 2008

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility 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