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

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep

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.

Study Overview

• Status: Completed
• Conditions: Surgical Skin Preparation
• Intervention / Treatment: Drug: ChloraPrep; Drug: ZuraPrep Clear Solution; Drug: ZuraPrep Vehicle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Sterling, Virginia, United States, 20164
      • Microbac Laboratories, Inc.

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ZuraPrep (70% IPA); Isopropyl alcohol (IPA) 70%	Drug: ZuraPrep Clear Solution; Apply topically.; Other Names: Isopropyl alcohol 70%; ZP
ACTIVE_COMPARATOR: ChloraPrep; Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%	Drug: ChloraPrep; Apply topically.; Other Names: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; CHG 2%/IPA 70%
PLACEBO_COMPARATOR: ZuraPrep Vehicle; Zurex Prep without IPA	Drug: ZuraPrep Vehicle; Apply topically.; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Reduction - Groin	A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.	30 seconds post product application
Bacterial Reduction - Abdomen	A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.	30 seconds post product application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region	Bacterial counts should not exceed baseline on the abdomen or groin region	6 hours post product applcation

Collaborators and Investigators

• Sponsor: Zurex Pharma, Inc.
• Investigators: Principal Investigator: M H Bashir, MD, Microbac Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2019
• Primary Completion (ACTUAL): May 12, 2019
• Study Completion (ACTUAL): September 26, 2019

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (ACTUAL): December 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Dermatologic Agents; Disinfectants; Ethanol; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: ZX-ZP-0092 / 865-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No