Preoperative Skin Preparation Evaluation
|Topical Antisepsis||Drug: Chlorhexidine gluconate Drug: ChloraPrep One Step Drug: Sterile saline||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control|
- 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 ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: CHG 2%-26 ml
Chlorhexidine gluconate in an aqueous base, 26 ml applicator
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
Other Name: ChloraPrep AQ
Active Comparator: ChloraPrep 26 ml
ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
Drug: ChloraPrep One Step
Other Name: Chlorhexidine gluconate 2% w/v and 70% v/v isopropyl alcohol
Placebo Comparator: Sterile Saline
Sterile salt water administered topically.
Drug: Sterile saline
0.9% NaCl solution
Other Name: Physiologic saline (0.9% NaCl)
Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.
This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636480
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Principal Investigator:||Daryl S Paulsen, PhD||President and CEO|