Clinical trial NCT00692484: Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
Official title: Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Antimicrobial
Antisepsis
Topical antisepsis
Lead sponsor: CareFusion
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
timeFrame: 10 minutes and 6 hours after application of test solutions
Secondary outcomes:
measure: Impact of blotting versus not blotting
timeFrame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: BioScience Laboratories
state: Montana
Study officials:
affiliation: President and CEO
name: Daryl S Paulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: