Perioperative Patient Skin Antiseptic Preparation Evaluation

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zurex Pharma, Inc.
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Ethanol

Criteria

Inclusion Criteria:

1. Be male or female and at least 18 years of age.

2. 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.

3. Be planning to undergo clean (class I wound) or clean-contaminated (class II wounds) surgery.

4. Expect to be available for up to 30-days after the surgery.

Exclusion Criteria:

1. Active infection or fever including evidence of infection at or adjacent to the operative site.

2. Immunosuppressed.

3. Kidney/liver failure.

4. Immunosuppressive therapy (chemotherapy, steroids) within the previous 1 week.

5. 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.