Phase 3
N=156
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Surgical Skin Preparation
Bottom Line
View on ClinicalTrials.gov: NCT03782103 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Bacterial Reduction - Groin — 4.133; 3.642; 1.277 log 10 CFU/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ZuraPrep Clear Solution (Drug); ChloraPrep (Drug); ZuraPrep Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zurex Pharma, Inc.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Reduction - Groin |
4.133; 3.642; 1.277 | — |
| PRIMARY Bacterial Reduction - Abdomen |
3.036; 3.087; 1.234 | — |
| SECONDARY Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region |
72 | — |
Summary
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects of any race
- Subjects in good general health
- Minimum bacterial 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.
- Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
- Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
- 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 (NCT03782103). 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.