Status:

COMPLETED

Perioperative Patient Skin Antiseptic Preparation Evaluation

Lead Sponsor:

Zurex Pharma, Inc.

Conditions:

Surgical Site Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 wi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 21 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 29 2022

Estimated Enrollment :

51 Patients enrolled

Trial Details

Trial ID

NCT04756804

Start Date

June 21 2021

End Date

September 29 2022

Last Update

March 20 2024

Active Locations (1)

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MCW/FH

Milwaukee, Wisconsin, United States, 53226