Phase 4
N=43
Topical Antimicrobial Effectiveness Testing
Antimicrobial Effectiveness
Bottom Line
View on ClinicalTrials.gov: NCT01366417 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Antimicrobial Efficacy — 2.21; 2.25 log 10 colony forming units / cm^2 — p=< 0.05
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
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antimicrobial Efficacy |
2.65; 2.60 | <0.05 sig |
| PRIMARY Antimicrobial Efficacy |
2.65; 2.60 | <0.05 sig |
Summary
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
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 the Screen Visit
Data sourced from ClinicalTrials.gov (NCT01366417). 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.