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Topical Antimicrobial Effectiveness Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01314703
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : August 31, 2012
Last Update Posted : November 1, 2012
Sponsor:
Information provided by (Responsible Party):
CareFusion

Tracking Information
First Submitted Date  ICMJE March 10, 2011
First Posted Date  ICMJE March 14, 2011
Results First Submitted Date  ICMJE February 8, 2012
Results First Posted Date  ICMJE August 31, 2012
Last Update Posted Date November 1, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
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. [ Time Frame: 10 minutes after single application of test material ]
the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2011)
Antimicrobial efficacy will be measured by the reduction of skin flora [ Time Frame: up to 6 hours ]
the measure of antimicrobial efficacy is the Log10 reduction of skin flora at treatment sites following application of the study materials relative to the Treatment Day baseline log 10 counts.
Change History Complete list of historical versions of study NCT01314703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Antimicrobial Effectiveness Testing
Official Title  ICMJE Test for Preoperative Skin Preparations
Brief Summary The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Antimicrobial Effectiveness
Intervention  ICMJE
  • Drug: ChloraPrep One-Step
    10.5 ml applicator preoperative skin preparation
  • Drug: 70% isopropyl alcohol
    10.5 ml applicator
    Other Name: Positive control
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2012)
27
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2011)
25
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314703
Other Study ID Numbers  ICMJE 371.1.02.15.11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CareFusion
Study Sponsor  ICMJE CareFusion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muhammad H Bashir, MD Microbiotest
PRS Account CareFusion
Verification Date October 2012

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