Preventing Staphylococcus Aureus Infections in Surgical Patients
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
University of Minnesota · NCT06378359
This study is testing different methods to see if cleaning out Staphylococcus aureus germs before surgery can help prevent infections in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06378359 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of a preoperative screening and decolonization protocol for Staphylococcus aureus (SA) in surgical outpatients. Participants will be assigned to one of four different approaches to decolonization, including a three-drug bundle and various preoperative treatments. The study will assess the eradication of SA carriage and compare healthcare utilization and costs associated with each approach. It is a single-center pilot trial conducted at the University of Minnesota Medical Center.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18 and older scheduled for surgery in specific specialties, such as orthopedic or urology, with anticipated surgery at least 10 days after enrollment.
Not a fit: Patients who are unable to give informed consent or have surgery scheduled within 10 days of enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of Staphylococcus aureus surgical site infections, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: Other studies have shown promise in using decolonization protocols to prevent surgical site infections, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota Medical Center and Clinics — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Susan Kline, MD, MPH — University of Minnesota
- Study coordinator: John Rottman
- Email: rothm029@umn.edu
- Phone: 612-626-3662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections