Topical Antimicrobial Effectiveness Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CareFusion
ClinicalTrials.gov Identifier:
NCT01314703
First received: March 10, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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


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 Preoperative Skin Preparations

Resource links provided by NLM:


Further study details as provided by CareFusion:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.


Enrollment: 27
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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
  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 Screening Day
  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: NCT01314703

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: NCT01314703     History of Changes
Other Study ID Numbers: 371.1.02.15.11
Study First Received: March 10, 2011
Results First Received: February 8, 2012
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014