In-vivo Efficacy of Patient Preoperative Prep
Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP
1 other identifier
interventional
440
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Start
First participant enrolled
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2017
CompletedResults Posted
Study results publicly available
July 19, 2021
CompletedFebruary 8, 2023
June 1, 2021
9 months
July 8, 2016
May 7, 2021
February 6, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Bacterial Reduction
A 3-log10 CFU/cm\^2 bacterial reduction on the inguinal region is considered a success.
10 minutes post product application
Bacterial Reduction - Abdomen
A 2-log10 CFU/cm\^2 bacterial reduction on the abdomen region is considered a success.
10 minutes post product application
Study Arms (3)
ZP (70% IPA)
EXPERIMENTALIsopropyl alcohol (IPA) 70%
ChloraPrep
ACTIVE COMPARATORChlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
ZP Vehicle
PLACEBO COMPARATORZP without IPA
Interventions
Apply topically.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MicroBioTest Laboratories
Sterling, Virginia, 20164, United States
Related Publications (1)
Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27.
PMID: 32131912DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Morgan
- Organization
- Zurex Pharma, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad H Bashir
Microbac Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 13, 2016
Study Start
July 27, 2016
Primary Completion
April 9, 2017
Study Completion
April 9, 2017
Last Updated
February 8, 2023
Results First Posted
July 19, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share