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Topical Antimicrobial Effectiveness Testing

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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

Study Description
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Brief Summary:
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Test for Preoperative Skin Preparations
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Intervention Details:
  • Drug: ChloraPrep One-Step
    10.5 ml applicator preoperative skin preparation
  • Drug: 70% isopropyl alcohol
    10.5 ml applicator
    Other Name: Positive control

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 Screening Day
Contacts and Locations
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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): NCT01314703


Locations
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United States, Virginia
Microbiotest
Sterling, Virginia, United States, 20164
Sponsors and Collaborators
CareFusion
Investigators
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Principal Investigator: Muhammad H Bashir, MD Microbiotest
More Information
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Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT01314703    
Other Study ID Numbers: 371.1.02.15.11
First Posted: March 14, 2011    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: November 1, 2012
Last Verified: October 2012