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

Recruiting

• Conditions: Surgical Site Infections; Staphylococcus Aureus Colonization; Healthcare Associated Infections
• Interventions: Other: Screening and decolonization for SA carriers with the 3 drug bundle; Other: No screening for SA; Other: no screening; Other: 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

• Registration Number: NCT06378359
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1a	Screening and decolonization for SA carriers with the 3 drug bundle	screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization
Arm 1b	No screening for SA	non SA carriers in this arm will get two pre-op showers with an antiseptic soap
Arm 2	no screening	giving pre-surgical patients the three drug decolonization bundle without screening. Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
Arm 3	Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.	giving pre-op nasal povidone iodine without screening
Arm 4	Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening	giving nasal alcohol gel without screening

Primary Outcome Measures

Name	Time	Method
Efficacy in eradicating Staphylococcus aureus (SA)	baseline	The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.

Trial Locations

Locations (1)

University of Minnesota Medical Center and Clinics; 🇺🇸 Minneapolis, Minnesota, United States