Actively Recruiting

Age: 18Years +
All Genders
ID06378359

Effectiveness of Screening and Decolonization of Staphylococcus aureus to Prevent Surgical Site Infections in Outpatient Surgery

Led by University of Minnesota · Updated on 2026-01-14

250

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of different approaches to screen for and remove Staphylococcus aureus (SA) bacteria before surgery. This study focuses on preventing SA colonization and surgical site infections in outpatients undergoing various surgeries, including orthopedic, urology, neuro, otolaryngology, plastic, general surgery, and OB/GYN procedures. The trial aims to compare four different SA decolonization methods to see which best eradicates SA carriage and reduces infection risks. Participants are assigned to one of four groups: Arm 1 involves screening for SA and giving a three-drug decolonization bundle (nasal mupirocin ointment, chlorhexidine gluconate body wash, and mouth rinse) for 5 days to those with SA, while non-carriers in this arm get two pre-op showers with chlorhexidine soap. Arm 2 gives all participants the three-drug bundle without screening. Arm 3 provides pre-op nasal povidone iodine on surgery day plus two pre-op chlorhexidine showers without screening. Arm 4 uses nasal alcohol gel on surgery day plus two pre-op chlorhexidine showers without screening. Participants will complete the decolonization protocol before surgery. Researchers will collect baseline cultures and assess eradication of SA from five body sites as the main outcome. Secondary outcomes include rates of SA surgical site infections and healthcare-associated infections. Monitoring includes verifying completion of the decolonization process and tracking infections. The study participation lasts from enrollment until surgery and includes follow-up to assess infection outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatients in orthopedic, urology, neuro, otolaryngology, plastic, general surgery, or OB/GYN clinics scheduled for surgery at participating sites
  • Surgery planned at least 10 days after enrollment to allow for cultures and decolonization
  • Age 18 years or older
  • Ability to complete the preoperative decolonization protocol as an outpatient
  • No antibiotic therapy at the time of, or within seven days before, baseline cultures
  • Patients having skin incisions as part of their scheduled surgery
Not Eligible

You will not qualify if you...

  • Inability to give informed consent
  • Surgery planned less than 10 days after baseline cultures

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Decolonization

Duration - Approximately 5 days before surgery

Participants receive preoperative decolonization according to their assigned group, which may include nasal mupirocin, chlorhexidine gluconate mouth rinse, chlorhexidine soap showers, nasal povidone-iodine, or nasal alcohol gel.

1 to 2 visits depending on assigned treatment

Surgery

Duration - Day of surgery

Participants undergo their planned surgery after completing the decolonization protocol.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of Minnesota Medical Center and Clinics

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

J

John Rottman

R

Reshma Suresh Kumar

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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