NCT01366417

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 31, 2012

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

June 2, 2011

Results QC Date

February 16, 2012

Last Update Submit

November 25, 2025

Conditions

Antimicrobial Effectiveness

Outcome Measures

Primary Outcomes (2)

  • Antimicrobial Efficacy

    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.

    30 seconds after treatment

  • Antimicrobial Efficacy

    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 treatment

Interventions

ChloraPrep One-StepDRUG

1.5 ml applicator patient preoperative skin preparation

70% isopropyl alcoholDRUG

Curity Alcohol Prep Pads

Also known as: Positive Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Microbiotest

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Interventions

2-Propanol

Intervention Hierarchy (Ancestors)

PropanolsAlcoholsOrganic Chemicals

Results Point of Contact

Title
Jennifer Raeder-Devens
Organization
CareFusion
jennifer.raeder-devens@carefusion.com
847-454-4939

Study Officials

  • Muhammad H Bashir, MD

    Microbiotest

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 11, 2025

Results First Posted

August 31, 2012

Record last verified: 2025-11

Locations

US(1)