Status:
COMPLETED
Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
Lead Sponsor:
C. R. Bard
Conditions:
Healthy
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00692484
Start Date
October 1 2007
End Date
February 1 2008
Last Update
November 26 2025
Active Locations (1)
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1
BioScience Laboratories
Bozeman, Montana, United States, 59715