- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831998
In-vivo Efficacy of Patient Preoperative Prep
February 6, 2023 updated by: Zurex Pharma, Inc.
Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
440
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Sterling, Virginia, United States, 20164
- MicroBioTest Laboratories
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ChloraPrep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
|
Apply topically.
Other Names:
|
EXPERIMENTAL: ZP (70% IPA)
Isopropyl alcohol (IPA) 70%
|
Apply topically.
Other Names:
|
PLACEBO_COMPARATOR: ZP Vehicle
ZP without IPA
|
Apply topically.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes post product application
|
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.
|
10 minutes post product application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad H Bashir, Microbac Laboratories, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 27, 2016
Primary Completion (ACTUAL)
April 9, 2017
Study Completion (ACTUAL)
April 9, 2017
Study Registration Dates
First Submitted
July 8, 2016
First Submitted That Met QC Criteria
July 11, 2016
First Posted (ESTIMATE)
July 13, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZX-ZP-0073 / 865-105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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