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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014