Test for Preoperative Skin Preparations

Topical Antimicrobial Effectiveness Testing

Sponsors

Lead sponsor: CareFusion

Source CareFusion
Brief Summary

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

Overall Status Completed
Start Date March 2011
Completion Date April 2011
Primary Completion Date April 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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. 10 minutes after single application of test material
Enrollment 27
Condition
Intervention

Intervention type: Drug

Intervention name: ChloraPrep One-Step

Description: 10.5 ml applicator preoperative skin preparation

Intervention type: Drug

Intervention name: 70% isopropyl alcohol

Description: 10.5 ml applicator

Other name: Positive control

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Muhammad H Bashir, MD Principal Investigator Microbiotest
Location
facility Microbiotest
Location Countries

United States

Verification Date

October 2012

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov