A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™
Overview
- Phase
- Phase 2
- Intervention
- ZuraPrep
- Conditions
- Surgical Site Infection
- Sponsor
- Zurex Pharma, Inc.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Calculations of mean log10 reductions from baseline populations
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.
Detailed Description
This is an open label pilot study to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied bilaterally to the skin of the abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness Testing of a Patient Preoperative Skin Preparation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects may be of either sex, at least 18 years of age and of any race.
- •Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria
- •Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products
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 14-day pre-test conditioning period or during the test period.
- •Use of topical or systemic antimicrobials, antibiotics, or steroids (other than hormones for contraception or post-menopausal indications), or any other product known to affect the normal microbial flora of the skin during the 14-day pre-test conditioning period or during the test period.
- •Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day pre-test conditioning period or during the test period.
- •Known 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 (CHG), citric acid, methylene blue, methylparaben, propylparaben, or isopropyl alcohol.
- •A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive).
- •Subjects must be unable to become pregnant, or willing to use an acceptable method of contraception to prevent pregnancy, if female of child-bearing potential.
- •Inability to become pregnant would include subjects who are:
- •Females unable to become pregnant (i.e., postmenopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, uterine ablation, or bilateral tubal ligation)
- •Females of child-bearing potential but using acceptable methods of contraception, including one of the following methods that have been used for at least 2 weeks prior to Treatment Day Visit.
- •Acceptable methods of contraception include one of the following methods:
Arms & Interventions
ZuraPrep Config 1
Isopropyl alcohol (IPA) 70% Standard scrub time.
Intervention: ZuraPrep
ZuraPrep Config 2
Isopropyl alcohol (IPA) 70% Half scrub time.
Intervention: ZuraPrep
ZuraPrep Vehicle
ZuraPrep without IPA
Intervention: ZuraPrep Vehicle
ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Intervention: Chloraprep
Outcomes
Primary Outcomes
Calculations of mean log10 reductions from baseline populations
Time Frame: 0-24 hours post dose
Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.