NCT06378359

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-01-29
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-04-22
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States