Preoperative Skin Preparation Evaluation

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sterile Saline	Sterile saline	Sterile salt water administered topically.
ChloraPrep 26 ml	ChloraPrep One Step	ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
CHG 2%-26 ml	Chlorhexidine gluconate	Chlorhexidine gluconate in an aqueous base, 26 ml applicator

Primary Outcome Measures

Name	Time	Method
3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites	10 minutes and 6 hours after application of test solutions

Secondary Outcome Measures