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Topical Antimicrobial Effectiveness Testing

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ClinicalTrials.gov Identifier: NCT01366417
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : August 31, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
CareFusion

Brief Summary:
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.

Condition or disease Intervention/treatment Phase
Antimicrobial Effectiveness Drug: ChloraPrep One-Step Drug: 70% isopropyl alcohol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Test for Preinjection Skin Preparation
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources


Intervention Details:
    Drug: ChloraPrep One-Step
    1.5 ml applicator patient preoperative skin preparation
    Drug: 70% isopropyl alcohol
    Curity Alcohol Prep Pads
    Other Name: Positive Control


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

  2. Antimicrobial Efficacy [ Time Frame: 10 minutes after treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366417


Locations
United States, Virginia
Microbiotest
Sterling, Virginia, United States, 20164
Sponsors and Collaborators
CareFusion
Investigators
Principal Investigator: Muhammad H Bashir, MD Microbiotest

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT01366417     History of Changes
Other Study ID Numbers: 371.1.04.19.11
First Posted: June 6, 2011    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: September 10, 2012
Last Verified: March 2012