- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00636480
Preoperative Skin Preparation Evaluation
Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59715
- BioScience Laboratories
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must 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 fourteen(14) day pre-test conditioning period or during the test period;
- Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period;
- Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period;
- Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol;
- A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures;
- Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child;
- Any active skin rashes or breaks in the skin of the test sites;
- A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study;
- Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation;
- Unwillingness to fulfill the performance requirements of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHG 2%-26 ml
Chlorhexidine gluconate in an aqueous base, 26 ml applicator
|
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 Names:
|
Active Comparator: ChloraPrep 26 ml
ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
|
Administer topically
Other Names:
|
Placebo Comparator: Sterile Saline
Sterile salt water administered topically.
|
0.9% NaCl solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
10 minutes and 6 hours after application of test solutions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daryl S Paulsen, PhD, President and CEO
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070921-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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