NCT02831816CompletedPhase 3
Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Zurex Pharma, Inc.
- Enrollment
- 640
- Locations
- 1
- Primary Endpoint
- Bacterial Reduction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
ZP (70% IPA)
Experimental
Isopropyl alcohol (IPA) 70%
Intervention: ZuraPrep (Drug)
ChloraPrep
Active Comparator
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
Intervention: ChloraPrep (Drug)
ZP Vehicle
Placebo Comparator
ZP without IPA
Intervention: ZP Vehicle (Drug)
Outcomes
Primary Outcomes
Bacterial Reduction
Time Frame: 10 minutes post product application
A a 3-log per cm2 bacterial reduction on the inguinal region is considered a success.
Bacterial Reduction - Abdomen
Time Frame: 10 minutes post product application
A 2-log per cm2 bacterial reduction on the abdomen region is considered a success.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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