In-vivo Efficacy of Patient Preoperative Prep

Phase 3CompletedNCT02831998

Zurex Pharma, Inc.440 enrolled

Overview

The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

440

Conditions

Surgical Skin Preparation

Interventions

ZuraPrepDRUG

Apply topically.

ChloraPrepDRUG

Apply topically.

ZP VehicleDRUG

Apply topically.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects of any race * Subjects in good health * Minimum skin flora 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. * Subjects with a history of skin sensitivity, skin allergies, or skin cancer. * Subjects who are pregnant, attempting pregnancy or nursing.

Locations (1)

MicroBioTest Laboratories

Sterling, Virginia, United States

Outcomes

Primary Outcomes

Bacterial Reduction

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

Time frame: 10 minutes post product application

Bacterial Reduction - Abdomen

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

Time frame: 10 minutes post product application

Data from ClinicalTrials.gov

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