Clinical trial NCT00636480: Preoperative Skin Preparation Evaluation
Official title: Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Topical Antisepsis
Keywords: Antimicrobial
Antisepsis
Lead sponsor: CareFusion
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites
timeFrame: 10 minutes and 6 hours after application of test solutions
Secondary outcomes:
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: BioScience Laboratories
state: Montana
Study officials:
affiliation: President and CEO
name: Daryl S Paulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: