Healthy
Conditions
Keywords
Antimicrobial, Antisepsis, Topical antisepsis
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.
Interventions
DRUGChlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
DRUGPovidone iodine
Povidone iodine scrub and paint. Administer topically.
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Impact of blotting versus not blotting | Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor |
Countries
United States
Outcome results
None listed