Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06378359

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Medical Center and Clinics

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Pragya Karki, MD

CONTACT

[email protected]

612-301-6316

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

No screening for SA

Other

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

No Screening

Other

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

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.

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

John Rottman

CONTACT

[email protected]

612-626-3662

Reshma Suresh Kumar

CONTACT

[email protected]

612-626-3662

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.