Perioperative Patient Skin Antiseptic Preparation Evaluation

Completed · Phase 3

Conditions studied: Surgical Site Infection

In brief

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.

Key facts

Study ID

NCT04756804

Run by

Zurex Pharma, Inc.

People needed

51

Starts

2021-06-21

Expected to finish

2022-09-29

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MCW/FH — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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