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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. Identifier: NCT01314703
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : August 31, 2012
Last Update Posted : November 1, 2012
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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

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

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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01314703

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

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Responsible Party: CareFusion Identifier: NCT01314703     History of Changes
Other Study ID Numbers: 371.
First Posted: March 14, 2011    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: November 1, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents