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Completed

NCT Number: NCT02831998

In-vivo Efficacy of Patient Preoperative Prep

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.

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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

MicroBioTest Laboratories

Sterling, Virginia, 20164, United States

About this study

The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.

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 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.

Treatment and study plan

ZuraPrep

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%

ZP Vehicle

Drug

Apply topically.

Other names: ZP without IPA

Primary outcomes

  1. Bacterial Reduction

    Time frame: 10 minutes 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: 10 minutes post product application

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

Sponsors and collaborators

Lead sponsor

Zurex Pharma, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2016
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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