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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infections; Healthcare Associated Infections; Staphylococcus Aureus Colonization
• Intervention / Treatment: Other: Screening and decolonization for SA carriers with the 3 drug bundle; Other: No screening for SA; Other: no screening; Other: 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

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: John Rottman; Phone Number: 612-626-3662; Email: rothm029@umn.edu
• Study Contact Backup: Name: Reshma Suresh Kumar; Phone Number: 612-626-3662; Email: sures175@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota Medical Center and Clinics
      • Contact: Pragya Karki, MD; Phone Number: 612-301-6316; Email: pkarki@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will recruit patients from outpatient surgical clinics at the time their surgical procedures are planned. The study team will work with collaborating surgeons at UMMC to identify these patients. The study will recruit the following NIH priority populations: low income groups, minority groups, women, the elderly and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care. These patients will be part of the surgical clinics' patient population and will be approached to participate in the study at the time their surgery is planned with their surgeon.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1a; screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization	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
Arm 1b; non SA carriers in this arm will get two pre-op showers with an antiseptic soap	Other: No screening for SA; All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
Arm 2; giving pre-surgical patients the three drug decolonization bundle without screening. 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
Arm 3; giving pre-op nasal povidone iodine 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.
Arm 4; giving nasal alcohol gel 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy in eradicating Staphylococcus aureus (SA)	The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.	baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Susan Kline, MD, MPH, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Cross Infection; Health Care Quality, Access, and Evaluation; Organic Chemicals; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Alcohols; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Ethanol; Mass Screening
• Other Study ID Numbers: IDIM-2023-32364

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No