CompletedPhase 3

Perioperative Patient Skin Antiseptic Preparation Evaluation

United States51 participantsStarted 2021-06-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Surgical Site Infection Occurrence

Timeframe: Within 30 days after surgery

Allergic Reaction and Skin Irritation

Timeframe: Within 30 days after surgery

Trial details

NCT IDNCT04756804

SponsorZurex Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-29

Results submitted2024-01-24

View on ClinicalTrials.gov More Surgical Site Infection trials