Clinical trial NCT06378359: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Official title: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Staphylococcus Aureus Colonization
Surgical Site Infections
Healthcare Associated Infections
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit patients from outpatient surgical clinics at the time their surgical procedures are planned. The study team will work with collaborating surgeons at UMMC to identify these patients. The study will recruit the following NIH priority populations: low income groups, minority groups, women, the elderly and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care. These patients will be part of the surgical clinics' patient population and will be approached to participate in the study at the time their surgery is planned with their surgeon.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy in eradicating Staphylococcus aureus (SA)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center and Clinics
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Susan Kline, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: