Clinical Evaluation of Patient Preoperative Prep

June 25, 2021 updated by: Zurex Pharma, Inc.

Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Bozeman, Montana, United States, 59718
        • BioScience Laboratories, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Drug: ChloraPrep
Apply topically.
Other Names:
  • CHG 2% / IPA 70%
  • Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
Experimental: ZP (70% IPA)
Isopropyl alcohol (IPA) 70%
Drug: ZuraPrep
Apply topically.
Other Names:
  • Isopropyl alcohol 70%
  • ZP
Placebo Comparator: ZP Vehicle
ZP without IPA
Drug: ZP Vehicle
Apply topically.
Other Names:
  • ZP without IPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial Reduction
Time Frame: 10 minutes post product application
A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.
10 minutes post product application
Bacterial Reduction - Abdomen
Time Frame: 10 minutes post product application
A 2-log per cm2 bacterial reduction on the abdomen region is considered a success.
10 minutes post product application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zurex Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2016

Primary Completion (Actual)

August 3, 2017

Study Completion (Actual)

August 3, 2017

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZX-ZP-0074 / 150316-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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