NCT06378359 · University of Minnesota
Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
What this study 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.
View original scientific description
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.
Interventions
OTHER
Screening and decolonization for SA carriers with the 3 drug bundle
nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse and CHG soap showers x 5 days and non-SA carriers receive 2 CHG pre-op showers
OTHER
No screening for SA
All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
OTHER
no screening
giving pre-surgical patients the three drug decolonization bundle without screening
OTHER
Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
OTHER
Nasal alcohol gel 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
Primary outcome measures
Efficacy in eradicating Staphylococcus aureus (SA)
Time frame: baseline
The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 14, 2026 · Source of record for eligibility and locations