Preoperative Skin Preparation Evaluation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00636480|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : February 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Topical Antisepsis||Drug: Chlorhexidine gluconate Drug: ChloraPrep One Step Drug: Sterile saline||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636480
|United States, Montana|
|Bozeman, Montana, United States, 59715|
|Principal Investigator:||Daryl S Paulsen, PhD||President and CEO|