Phase 3
N=440
In-vivo Efficacy of Patient Preoperative Prep
Surgical Skin Preparation
Bottom Line
View on ClinicalTrials.gov: NCT02831998 ↗Enrolled (actual)
440
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Bacterial Reduction — 4.83; 4.78; 2.23 log10 CFU/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ZuraPrep (Drug); ChloraPrep (Drug); ZP Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zurex Pharma, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Reduction |
4.83; 4.78; 2.23 | — |
| PRIMARY Bacterial Reduction - Abdomen |
3.35; 3.34; 1.47 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02831998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.