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Clinical Trials/NCT02831816
NCT02831816CompletedPhase 3

Clinical Evaluation of ZP, A Patient Preoperative Skin Preparation

Zurex Pharma, Inc.1 site in 1 country640 target enrollmentStarted: August 3, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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