Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

November 25, 2025 updated by: C. R. Bard

Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint

Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA.

Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Bozeman, Montana, United States, 59715
        • BioScience Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Free of dermatoses, cuts, lesions, or other skin disorders around test sites
  • must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and agree to abstain from these materials until completion of the study

Exclusion Criteria:

  • Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 7 day pre-test period or during the test period
  • exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period
  • use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period
  • known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine
  • active skin rashes or breaks in the skin of the test sites
  • currently active skin disease or inflammatory skin condition, including contact dermatitis
  • showering or bathing within the 72 hour period prior to sampling
  • participation in a clinical study in the past 7 days or current participation in another clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Chlorhexidine gluconate 2%
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
Other Names:
  • ChloraPrep AQ
Active Comparator: 2
Povidone iodine scrub and paint
Drug: Povidone iodine
Povidone iodine scrub and paint. Administer topically.
Other Names:
  • Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
Time Frame: 10 minutes and 6 hours after application of test solutions
10 minutes and 6 hours after application of test solutions

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of blotting versus not blotting
Time Frame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor
Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: Daryl S Paulsen, PhD, President and CEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimated)

June 6, 2008

Study Record Updates

Last Update Posted (Estimated)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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