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RECRUITING
NCT06378359

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

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2024-01-29

Completion Date

2026-12-31

Last Updated

2026-01-14

Healthy Volunteers

No

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

Locations (1)

University of Minnesota Medical Center and Clinics

Minneapolis, Minnesota, United States