Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: Chloraprep
* Drug: ZuraPrep
* Drug: ZuraPrep Vehicle


Participation Criteria
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Eligibility Criteria
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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: Male 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: Systemic birth control (the same type of birth control for at least 3 months prior to entering the study and continuation of this type of birth control throughout the study) Double barrier methods (condom with spermicide or diaphragm with spermicide) IUD Vasectomized partner; or Abstinence from sexual intercourse Any large tattoos, scars, active skin rashes, or breaks in the skin of the test sites. Dermatoses, cuts, lesions, or other skin disorders on or around the test sites A currently active skin disease or inflammatory skin condition (e.g., contact dermatitis) that, in the opinion of the Consulting Physician or Principal Investigator, would compromise subject safety or study integrity. Showering, bathing, or swimming within the 72 hour period prior to Baseline Day, the first Test Day, and throughout the test period. Participation in another clinical study in the past 30 days or current participation in another clinical study. Any medical condition or use of any medications that, in the opinion of the Medical Expert/Consulting Physician or Principal Investigator, should preclude participation. Unwillingness to fulfill the performance requirements of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZuraPrep Config 1<br>Isopropyl alcohol (IPA) 70% Standard scrub time. | Drug: ZuraPrep<br>* Apply topically.<br>* Other names: Isopropyl alcohol 70%;|
| Experimental: ZuraPrep Config 2<br>Isopropyl alcohol (IPA) 70% Half scrub time. | Drug: ZuraPrep<br>* Apply topically.<br>* Other names: Isopropyl alcohol 70%;|
| Placebo Comparator: ZuraPrep Vehicle<br>ZuraPrep without IPA | Drug: ZuraPrep Vehicle<br>* Apply topically.<br>* Other names: ZuraPrep Placebo;|
| Active Comparator: ChloraPrep<br>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | Drug: Chloraprep<br>* Apply topically.<br>* Other names: CHG 2% / IPA 70%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculations of mean log10 reductions from baseline populations | 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. | 0-24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ZuraPrep, Antimicrobial, Bio-Science Laboratories, Zurex Pharma, Surgical/Patient preoperative skin preparation