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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06378359
Status
Recruiting
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Conditions

  • Healthcare Associated Infections
  • Staphylococcus Aureus Colonization
  • Surgical Site Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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 Dates

Start date
Jan 29, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Arm 1a
    screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization
  • Arm: Arm 1b
    non SA carriers in this arm will get two pre-op showers with an antiseptic soap
  • Arm: Arm 2
    giving pre-surgical patients the three drug decolonization bundle without screening. Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
  • Arm: Arm 3
    giving pre-op nasal povidone iodine without screening
  • Arm: Arm 4
    giving nasal alcohol gel without screening

Primary Outcome Measure

Efficacy in eradicating Staphylococcus aureus (SA) [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota Medical Center and ClinicsMinneapolisMinnesota55414
Pragya Karki, MD
[email protected]
612-301-6316

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By research site
University of Minnesota Medical Center and Clinics· Minneapolis, MN

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