Clinical Evaluation of Patient Preoperative Prep
Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation
1 other identifier
interventional
640
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 P75+ for phase_3
Started Aug 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 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Start
First participant enrolled
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedResults Posted
Study results publicly available
July 16, 2021
CompletedJuly 16, 2021
June 1, 2021
1 year
July 11, 2016
May 6, 2021
June 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Bacterial Reduction
A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.
10 minutes post product application
Bacterial Reduction - Abdomen
A 2-log per cm2 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)
BioScience Laboratories, Inc.
Bozeman, Montana, 59718, 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.
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 11, 2016
First Posted
July 13, 2016
Study Start
August 3, 2016
Primary Completion
August 3, 2017
Study Completion
August 3, 2017
Last Updated
July 16, 2021
Results First Posted
July 16, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share