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

Phase 3

Completed

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

• Registration Number: NCT03782103
• Lead Sponsor: Zurex Pharma, Inc.

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.

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 Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-20
• Study Start: 2019-01-25
• Primary Completion: 2019-05-12
• Study Completion: 2019-09-26
• Disposition First Submitted: 2020-06-29
• Status Verified: 2021-06
• Results First Submitted: 2022-05-23
• Results First Submitted QC: 2022-06-24
• Disposition First Submitted QC: 2022-06-24
• Results First Posted: 2022-07-21
• Disposition First Posted: 2022-07-21
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZuraPrep Vehicle	ZuraPrep Vehicle	Zurex Prep without IPA
ChloraPrep	ChloraPrep	Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
ZuraPrep (70% IPA)	ZuraPrep Clear Solution	Isopropyl alcohol (IPA) 70%

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Microbac Laboratories, Inc.; 🇺🇸 Sterling, Virginia, United States