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

Zurex Pharma, Inc.156 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

156

Conditions

Surgical Skin Preparation

Interventions

ZuraPrep Clear SolutionDRUG

Apply topically.

ChloraPrepDRUG

Apply topically.

ZuraPrep VehicleDRUG

Apply topically.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Microbac Laboratories, Inc.

Sterling, Virginia, United States

Outcomes

Primary Outcomes

Bacterial Reduction - Groin

A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.

Time frame: 30 seconds post product application

Bacterial Reduction - Abdomen

A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.

Time frame: 30 seconds post product application

Secondary Outcomes

Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region

Bacterial counts should not exceed baseline on the abdomen or groin region

Time frame: 6 hours post product applcation

Data from ClinicalTrials.gov

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