In-vivo Efficacy of Patient Preoperative Prep

Phase 3

Completed

• Conditions: Surgical Skin Preparation
• Interventions: Drug: ZP Vehicle; Drug: ZuraPrep; Drug: ChloraPrep

• Registration Number: NCT02831998
• Lead Sponsor: Zurex Pharma, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Study Start: 2016-07-27
• Primary Completion: 2017-04-09
• Study Completion: 2017-04-09
• Disposition First Submitted: 2018-07-20
• Disposition First Submitted QC: 2018-07-20
• Disposition First Posted: 2018-07-24
• Results First Submitted: 2021-05-07
• Status Verified: 2021-06
• Results First Submitted QC: 2021-07-15
• Results First Posted: 2021-07-19
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZP Vehicle	ZP Vehicle	ZP without IPA
ZP (70% IPA)	ZuraPrep	Isopropyl alcohol (IPA) 70%
ChloraPrep	ChloraPrep	Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

Primary Outcome Measures

Name	Time	Method
Bacterial Reduction	10 minutes post product application	A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
Bacterial Reduction - Abdomen	10 minutes post product application	A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.

Trial Locations

Locations (1)

MicroBioTest Laboratories; 🇺🇸 Sterling, Virginia, United States