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Topical Antimicrobial Effectiveness Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CareFusion
ClinicalTrials.gov Identifier:
NCT01366417
First received: June 2, 2011
Last updated: August 31, 2012
Last verified: March 2012
History of Changes

June 2, 2011
August 31, 2012
May 2011
June 2011   (final data collection date for primary outcome measure)
  • Antimicrobial Efficacy [ Time Frame: 30 seconds after treatment ] [ Designated as safety issue: No ]
    Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.
  • Antimicrobial Efficacy [ Time Frame: 10 minutes after treatment ] [ Designated as safety issue: No ]
    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.
Antimicrobial efficacy will be measured by the reduction of skin flora [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
the measure of antimicrobial efficacy is the Log 10 reduction of skin flora at treatment sites following application of the study materials relative to the treatment day baseline microbial counts.
Complete list of historical versions of study NCT01366417 on ClinicalTrials.gov Archive Site
Not Provided
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Topical Antimicrobial Effectiveness Testing
Test for Preinjection Skin Preparation

The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Antimicrobial Effectiveness
  • Drug: ChloraPrep One-Step
    1.5 ml applicator patient preoperative skin preparation
  • Drug: 70% isopropyl alcohol
    Curity Alcohol Prep Pads
    Other Name: Positive Control
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01366417
371.1.04.19.11
No
CareFusion
CareFusion
Not Provided
Principal Investigator: Muhammad H Bashir, MD Microbiotest
CareFusion
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP