Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients

Recruiting now

Conditions studied: Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections

In brief

The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent. The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap. The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome.

Key facts

Study ID

NCT06378359

Run by

University of Minnesota

People needed

250

Starts

2024-01-29

Expected to finish

2026-12-31

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and OB/GYN clinics who are scheduled to undergo surgery at participating trial sites.
• Anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol.
• Age ≥ 18 years
• Ability to complete the decolonization protocol pre-operatively as an outpatient.
• No antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. Standard pre-op antibiotic prophylaxis given.
• Patients are having skin incisions as part of their scheduled surgical procedure.

You may not qualify if…

• Inability to give informed consent
• Surgery anticipated <10 days after the baseline cultures

Where it is running

• University of Minnesota Medical Center and Clinics — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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