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Completed

NCT Number: NCT00692484

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

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

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BioScience Laboratories

Bozeman, Montana, 59715, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine gluconate

Drug

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

Other names: ChloraPrep AQ

Povidone iodine

Drug

Povidone iodine scrub and paint. Administer topically.

Other names: Betadine

Primary outcomes

  1. 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

Secondary outcomes

  1. Impact of blotting versus not blotting

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

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2008
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.