Topical Antimicrobial Effectiveness Testing

NCT ID: NCT01314703

Last Updated: 2012-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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Conditions

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Antimicrobial Effectiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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ChloraPrep One-Step

10.5 ml applicator preoperative skin preparation

Intervention Type DRUG

70% isopropyl alcohol

10.5 ml applicator

Intervention Type DRUG

Other Intervention Names

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Positive control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CareFusion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad H Bashir, MD

Role: PRINCIPAL_INVESTIGATOR

Microbiotest

Locations

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Microbiotest

Sterling, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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371.1.02.15.11

Identifier Type: -

Identifier Source: org_study_id