Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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..
- Who it may be relevant to
- Registry conditions: Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Efficacy in eradicating Staphylococcus aureus (SA) [Time frame: baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Minnesota Medical Center and Clinics — Minneapolis
Identifiers
NCT: NCT06378359 · IDIM-2023-32364