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A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™ (ZX-ZP-0035)
The purpose of this pilot study is to evaluate antimicrobial properties of a single test product, a vehicle product and a reference product applied in two different areas when used as a patient preoperative skin preparation.
Details
| Lead sponsor | Zurex Pharma, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 64 |
| Start date | 2014-08 |
| Completion | 2014-10 |
Conditions
- Surgical Site Infection
Interventions
- Chloraprep
- ZuraPrep
- ZuraPrep Vehicle
Primary outcomes
- Calculations of mean log10 reductions from baseline populations — 0-24 hours post dose
Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.
Countries
United States