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

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

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

Sponsors & Collaborators

• University of Minnesota

  lead OTHER

Principal Investigators

• Susan Kline, MD, MPH · University of Minnesota

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-29

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations