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

NCT ID: NCT00692484

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-02-29

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Chlorhexidine gluconate 2%

Group Type: EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type: DRUG

Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.

2

Povidone iodine scrub and paint

Group Type: ACTIVE_COMPARATOR

Povidone iodine

Intervention Type: DRUG

Povidone iodine scrub and paint. Administer topically.

Interventions

Chlorhexidine gluconate

Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.

Intervention Type: DRUG

Povidone iodine

Povidone iodine scrub and paint. Administer topically.

Intervention Type: DRUG

Other Intervention Names

ChloraPrep AQ; Betadine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daryl S Paulsen, PhD

Role: PRINCIPAL_INVESTIGATOR

President and CEO

Locations

BioScience Laboratories

Bozeman, Montana, United States

Countries

United States

Other Identifiers

060629

Identifier Type: -

Identifier Source: org_study_id