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

NCT00692484 | Completed Phase 3

• 1 other identifier: 060629
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Antimicrobial; Antisepsis; Topical antisepsis

Outcome Measures

Primary Outcomes (1)

• 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites

  10 minutes and 6 hours after application of test solutions

Secondary Outcomes (1)

• Impact of blotting versus not blotting

  Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor

Study Arms (2)

1

EXPERIMENTAL

Chlorhexidine gluconate 2%

Drug: Chlorhexidine gluconate

2

ACTIVE COMPARATOR

Povidone iodine scrub and paint

Drug: Povidone iodine

Interventions

Chlorhexidine gluconate DRUG

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

Also known as: ChloraPrep AQ

1

Povidone iodine DRUG

Povidone iodine scrub and paint. Administer topically.

Also known as: Betadine

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

BioScience Laboratories

Bozeman, Montana, 59715, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconate; Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Daryl S Paulsen, PhD

  President and CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: October 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)