Healthcare Associated Infections, Staphylococcus Aureus Colonization, Surgical Site Infections
Conditions
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.
Interventions
OTHERScreening 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
OTHERNo screening for SA
All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
OTHERno screening
giving pre-surgical patients the three drug decolonization bundle without screening
OTHERNasal 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.
OTHERNasal 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
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactJohn Rottman
Backup ContactReshma Suresh Kumar
Outcome results
None listed