Actively Recruiting
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Led by University of Minnesota · Updated on 2026-01-14
250
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible outpatients in orthopedic, urology, neuro, otolaryngology, plastic, general surgery, or OB/GYN clinics scheduled for surgery at a participating site
- Surgery scheduled at least 10 days after enrollment to allow time for cultures and treatment
- Age 18 years or older
- Ability to complete the decolonization protocol before surgery as an outpatient
- No antibiotic therapy at enrollment or within 7 days before baseline cultures, and no antibiotics before surgery except standard prophylaxis
- Surgery involves skin incisions
You will not qualify if you...
- Unable to give informed consent
- Surgery expected less than 10 days after baseline cultures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota Medical Center and Clinics
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
J
John Rottman
CONTACT
R
Reshma Suresh Kumar
CONTACT
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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