Phase 4 N=35 Single-blind Other

Topical Antimicrobial Effectiveness Testing

Antimicrobial Effectiveness

Bottom Line

View on ClinicalTrials.gov: NCT01314703 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count. — 2.8469; 2.5328; 4.038; 3.5295 log 10 colony forming units

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ChloraPrep One-Step (Drug); 70% isopropyl alcohol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: C. R. Bard
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.	2.8469; 2.5328; 4.038; 3.5295	—

Summary

The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.

Eligibility Criteria

Inclusion Criteria

in good general health
have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.

Exclusion Criteria

topical or systemic antimicrobial exposure within 14 days prior to Screening Day

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01314703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.