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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
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Antimicrobial Effectiveness
Interventions: Drug: ChloraPrep One-Step
Drug: 70% isopropyl alcohol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject/first visit: May 12, 2011 Last subject/last visit: June 8, 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
43 subjects entered screening phase.25 subjects had qualifying treatment day baseline counts and completed the study.

Reporting Groups
  Description
ChloraPrep One Step and 70% Isopropyl Alcohol All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)

Participant Flow:   Overall Study
    ChloraPrep One Step and 70% Isopropyl Alcohol  
STARTED     43  
Signed Informed Consent     43 [1]
Completed Screen Visit     33 [2]
Completed Treatment Visit     28 [3]
Completed the Study     28 [4]
Discontinued Prior to Treatment     5 [5]
Excluded From Analysis     3 [6]
COMPLETED     25 [7]
NOT COMPLETED     18  
[1] Microbial samples were taken from 43 subjects for screening baseline.
[2] 33 subjects had qualifying screening bacterial counts and were eligible for the Treatment Visit
[3] 28 subjects were treated with ChloraPrep and 70% Isopropyl Alcohol (single topical treatment)
[4] treatment baseline microbial counts not available until after treatment; subjects not evaluable
[5] 5 eligible subjects were not treated because enrollment target of 25 was met and enrollment closed.
[6] 3 subjects did not have qualifying Treatment Day microbial counts and were excluded from analysis
[7] 25 subjects included in the analysis



  Baseline Characteristics
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Reporting Groups
  Description
ChloraPrep One Step and 70% Isopropyl Alcohol All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)

Baseline Measures
    ChloraPrep One Step and 70% Isopropyl Alcohol  
Number of Participants  
[units: participants]
 		  28  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  36  ± 16.71105  
Gender  
[units: participants]
 		 
Female     16  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     28  



  Outcome Measures
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1.  Primary:   Antimicrobial Efficacy   [ Time Frame: 30 seconds after treatment ]
  Show Outcome Measure 1

2.  Primary:   Antimicrobial Efficacy   [ Time Frame: 10 minutes after treatment ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jennifer Raeder-Devens
Organization: CareFusion
phone: 847-454-4939
e-mail: jennifer.raeder-devens@carefusion.com


No publications provided


Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT01366417     History of Changes
Other Study ID Numbers: 371.1.04.19.11
Study First Received: June 2, 2011
Results First Received: February 16, 2012
Last Updated: August 31, 2012
Health Authority: United States: Microbiotest Internal Institutional Review Board