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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
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Test for Preinjection Skin Preparation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CareFusion:

Primary Outcome Measures:
  • Antimicrobial Efficacy [ Time Frame: 30 seconds after treatment ] [ Designated as safety issue: No ]
    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.

  • Antimicrobial Efficacy [ Time Frame: 10 minutes after treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366417

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

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

ClinicalTrials.gov processed this record on May 16, 2013