Expired Study
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Bozeman, Montana 59715


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

070921-103


NCT ID:

NCT00636480


Secondary ID:


Study Acronym:


Brief Title:

Preoperative Skin Preparation Evaluation


Official Title:

Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

16 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

CareFusion


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daryl S Paulsen, PhD
Principal Investigator
President and CEO

Study Dates

Start Date:October 2007
Completion Date:March 2008
Completion Type:Actual
Primary Completion Date:March 2008
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 19, 2013
First Received Date:March 11, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Chlorhexidine gluconate
Description:Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
Arm Name:CHG 2%-26 ml
Other Name:ChloraPrep AQ
Intervention Type:Drug
Name:ChloraPrep One Step
Description:Administer topically
Arm Name:ChloraPrep 26 ml
Other Name:Chlorhexidine gluconate 2% w/v and 70% v/v isoprop
Intervention Type:Drug
Name:Sterile saline
Description:0.9% NaCl solution
Arm Name:Sterile Saline
Other Name:Physiologic saline (0.9% NaCl)

Study Arms

Study Arm Type:Experimental
Arm Name:CHG 2%-26 ml
Description:Chlorhexidine gluconate in an aqueous base, 26 ml applicator
Study Arm Type:Active Comparator
Arm Name:ChloraPrep 26 ml
Description:ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
Study Arm Type:Placebo Comparator
Arm Name:Sterile Saline
Description:Sterile salt water administered topically.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:CareFusion

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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