In-vivo Efficacy of Patient Preoperative Prep

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-27

Study Completion Date

2017-04-09

Brief Summary

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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.

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Detailed Description

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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.

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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ZP (70% IPA)

Isopropyl alcohol (IPA) 70%

Group Type EXPERIMENTAL

ZuraPrep

Intervention Type DRUG

Apply topically.

ChloraPrep

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

Group Type ACTIVE_COMPARATOR

ChloraPrep

Intervention Type DRUG

Apply topically.

ZP Vehicle

ZP without IPA

Group Type PLACEBO_COMPARATOR

ZP Vehicle

Intervention Type DRUG

Apply topically.

Interventions

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ZuraPrep

Apply topically.

Intervention Type DRUG

ChloraPrep

Apply topically.

Intervention Type DRUG

ZP 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% ZP without IPA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes