Recruiting

Screening & Decolonization

Sponsor:

University of Minnesota

Code:

NCT06378359

Conditions

Staphylococcus Aureus Colonization

Surgical Site Infections

Healthcare Associated Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Screening and decolonization for SA carriers with the 3 drug bundle

No screening for SA

no screening

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

Study Details

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.

Conditions

Staphylococcus Aureus Colonization

Surgical Site Infections

Healthcare Associated Infections

Study ID

NCT06378359

Start date

Jan 29, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm 1a

screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization

Arm 1b

non SA carriers in this arm will get two pre-op showers with an antiseptic soap

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 3

giving pre-op nasal povidone iodine without screening

Arm 4

giving nasal alcohol gel without screening

Interventions

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

No screening for SA

All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash

no screening

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.

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

Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Minnesota Medical Center and Clinics

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-14.