Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
|ClinicalTrials.gov Identifier: NCT00692484|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : April 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Chlorhexidine gluconate Drug: Povidone iodine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||October 2007|
|Primary Completion Date :||February 2008|
|Study Completion Date :||February 2008|
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
- 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 ]
- Impact of blotting versus not blotting [ Time Frame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692484
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Principal Investigator:||Daryl S Paulsen, PhD||President and CEO|