In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)

Study Overview
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Brief Summary
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The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.

Detailed Description
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The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.

Official Title
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Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep

Conditions
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Surgical Skin Preparation

Intervention / Treatment
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* Drug: ZuraPrep Clear Solution
* Drug: ChloraPrep
* Drug: ZuraPrep Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of any race Subjects in good general health Minimum bacterial baseline requirements on abdomen and groin Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area. Exclusion Criteria: Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics. Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment. Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate. Subjects with a history of skin sensitivity, skin allergies, or skin cancer. Subjects who are pregnant, attempting pregnancy or nursing.

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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZuraPrep (70% IPA)<br>Isopropyl alcohol (IPA) 70% | Drug: ZuraPrep Clear Solution<br>* Apply topically.<br>* Other names: ZP;|
| Active Comparator: ChloraPrep<br>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | Drug: ChloraPrep<br>* Apply topically.<br>* Other names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%;|
| Placebo Comparator: ZuraPrep Vehicle<br>Zurex Prep without IPA | Drug: ZuraPrep Vehicle<br>* Apply topically.<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Reduction - Groin | A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success. | 30 seconds post product application | 
| Bacterial Reduction - Abdomen | A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success. | 30 seconds post product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region | Bacterial counts should not exceed baseline on the abdomen or groin region | 6 hours post product applcation |