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

NCT06378359 | Recruiting

• 1 other identifier: IDIM-2023-32364
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Staphylococcus Aureus Colonization; Surgical Site Infections; Healthcare Associated Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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

Arm 1b

non SA carriers in this arm will get two pre-op showers with an antiseptic soap

Other: No screening for SA

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

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.

Arm 4

giving nasal alcohol gel without screening

Other: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening

Interventions

Screening and decolonization for SA carriers with the 3 drug bundle OTHER

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 1a

No screening for SA OTHER

All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash

Arm 1b

no screening OTHER

giving pre-surgical patients the three drug decolonization bundle without screening

Arm 2

Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. OTHER

Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.

Arm 3

Nasal alcohol gel 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

Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to give informed consent
• Surgery anticipated \<10 days after the baseline cultures

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center and Clinics

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection

Interventions

Mass Screening; Ethanol

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Alcohols; Organic Chemicals

Study Officials

• Susan Kline, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Rottman

CONTACT

612-626-3662; rothm029@umn.edu

Reshma Suresh Kumar

CONTACT

612-626-3662; sures175@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 22, 2024
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)