Phase 3
Completed N=440
In-vivo Efficacy of Patient Preoperative Prep
Surgical Skin Preparation
Source: ClinicalTrials.gov NCT02831998 ↗
Enrolled (actual)
440
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Bacterial Reduction — 4.83; 4.78; 2.23 log10 CFU/cm^2
◆ Published Evidence
Emerging
7citations · ~1 / year
Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis.
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.
Linked Publications
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Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.