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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint|
- 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 ] [ Designated as safety issue: No ]
- Impact of blotting versus not blotting [ Time Frame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Chlorhexidine gluconate 2%
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
Other Name: ChloraPrep AQ
Active Comparator: 2
Povidone iodine scrub and paint
Drug: Povidone iodine
Povidone iodine scrub and paint. Administer topically.
Other Name: Betadine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692484
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Principal Investigator:||Daryl S Paulsen, PhD||President and CEO|