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Pilot Clinical Evaluation to Characterize in Vivo Effects of Topically Applied ZuraPrep & ZuraPrep Vehicle

NCT02578771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2017-07-17

No results posted yet for this study

Summary

ZuraPrep is being evaluated for efficacy as a preoperative skin preparation solution to demonstrate its immediate and persistent antimicrobial properties. At least 72 subjects will be randomized utilizing bilateral applications on abdomen and groin. ZuraPrep active product and reference positive control will be compared; ZuraPrep non-active and negative control will be compared. Each subject will receive two of the planned treatments, one on the left side of body and one of the right. Study duration for subjects - 3 to 4 weeks.

Conditions

  • Surgical Site Infection

Interventions

DRUG

ZuraPrep with 70% IPA

Apply topically

DRUG

ZuraPrep without 70% IPA

Apply topically. 0% IPA

DRUG

ChloraPrep CHG/IPA Teal Tint

Apply topically

OTHER

Normal Saline

Apply topically

Sponsors & Collaborators

  • Zurex Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • M. Hamid Barshir, MD · MicroBioTest

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578771 on ClinicalTrials.gov