Phase 3
N=51
Perioperative Patient Skin Antiseptic Preparation Evaluation
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT04756804 ↗Enrolled (actual)
51
Serious AEs
41.2%
Results posted
Mar 2024
Primary outcome: Primary: Surgical Site Infection Occurrence — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 70% v/v Isopropyl Alcohol Surgical Solution (Drug); 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zurex Pharma, Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Site Infection Occurrence |
0; 1 | — |
| PRIMARY Allergic Reaction and Skin Irritation |
1; 1 | — |
| SECONDARY Subgroup Analysis of Rates of Surgical Site Infections |
0; 1; 0; 0 | — |
| SECONDARY Subgroup Analysis of Rates of Surgical Site Infections |
0; 1; 0; 0 | — |
Summary
This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
Eligibility Criteria
Inclusion Criteria
- Be male or female and at least 18 years of age.
- Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English.
- Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.
- Expect to be available for up to 30-days after the surgery.
Exclusion Criteria
- Active infection or fever including evidence of infection at or adjacent to the operative site.
- Immunosuppressed.
- Kidney/liver failure.
- Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.
- Any history of allergy to chlorhexidine or isopropyl alcohol or any other component in ZuraGard including citric acid, sodium citrate, methylparaben, or propylparaben, and FD&C Yellow #6.
Data sourced from ClinicalTrials.gov (NCT04756804). 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.