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

Recruitingn/aAges 18 Years - anyAllUniversity of Minnesota
NCT06378359 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Inability to give informed consent * Surgery anticipated \<10 days after the baseline cultures
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What it tests

  • Screening and decolonization for SA carriers with the 3 drug bundle
  • No screening for SA
  • no screening
  • Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
  • Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
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Where

1 site
University of Minnesota Medical Center and Clinics
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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