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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2019-09-26

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.

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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.

Conditions

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Surgical Skin Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ZuraPrep (70% IPA)

Isopropyl alcohol (IPA) 70%

Group Type EXPERIMENTAL

ZuraPrep Clear Solution

Intervention Type DRUG

Apply topically.

ChloraPrep

Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

Group Type ACTIVE_COMPARATOR

ChloraPrep

Intervention Type DRUG

Apply topically.

ZuraPrep Vehicle

Zurex Prep without IPA

Group Type PLACEBO_COMPARATOR

ZuraPrep Vehicle

Intervention Type DRUG

Apply topically.

Interventions

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ZuraPrep Clear Solution

Apply topically.

Intervention Type DRUG

ChloraPrep

Apply topically.

Intervention Type DRUG

ZuraPrep Vehicle

Apply topically.

Intervention Type DRUG

Other Intervention Names

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Isopropyl alcohol 70% ZP CHG 2%/IPA 70% Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Vehicle

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes