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

NCT03782103 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ZX-ZP-0092 / 865-107
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Skin Preparation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region

  6 hours post product applcation

Study Arms (3)

ZuraPrep (70% IPA)

EXPERIMENTAL

Isopropyl alcohol (IPA) 70%

Drug: ZuraPrep Clear Solution

ChloraPrep

ACTIVE COMPARATOR

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

Drug: ChloraPrep

ZuraPrep Vehicle

PLACEBO COMPARATOR

Zurex Prep without IPA

Drug: ZuraPrep Vehicle

Interventions

ZuraPrep Clear Solution DRUG

Apply topically.

Also known as: Isopropyl alcohol 70%, ZP

ZuraPrep (70% IPA)

ChloraPrep DRUG

Apply topically.

Also known as: CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

ChloraPrep

ZuraPrep Vehicle DRUG

Apply topically.

Also known as: Vehicle

ZuraPrep Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zurex Pharma, Inc.: lead

Study Sites (1)

Microbac Laboratories, Inc.

Sterling, Virginia, 20164, United States

Location

MeSH Terms

Interventions

Ethanol; Chromogranins; chlorhexidine gluconate; citrate, isopropyl alcohol, methylene blue, parabens drug combination

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Results Point of Contact

• Title: Andrew Morgan Exec. VP RA/QA Clinical
• Organization: Zurex Pharma

amorgan1@charter.net

16082175239

Study Officials

• M H Bashir, MD

  Microbac Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: January 25, 2019
• Primary Completion: May 12, 2019
• Study Completion: September 26, 2019
• Last Updated: February 8, 2023
• Results First Posted: July 21, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)