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Completed

NCT Number: NCT03782103

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

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.

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Key information

Conditions

Surgical Skin Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Microbac Laboratories, Inc.

Sterling, Virginia, 20164, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZuraPrep Clear Solution

Drug

Apply topically.

Other names: Isopropyl alcohol 70%, ZP

Chloraprep

Drug

Apply topically.

Other names: CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

ZuraPrep Vehicle

Drug

Apply topically.

Other names: Vehicle

Primary outcomes

  1. Bacterial Reduction - Groin

    Time frame: 30 seconds post product application

    A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.

  2. Bacterial Reduction - Abdomen

    Time frame: 30 seconds post product application

    A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.

Secondary outcomes

  1. Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region

    Time frame: 6 hours post product applcation

    Bacterial counts should not exceed baseline on the abdomen or groin region

Sponsors and collaborators

Lead sponsor

Zurex Pharma, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep

Acronym: ZP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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