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.
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.
Inability to give informed consent
Surgery anticipated <10 days after the baseline cultures
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.
Cohort
Prospective
Screening and decolonization for SA carriers with the 3 drug bundle
Other interventionnasal 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 interventionAll receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
no screening
Other interventiongiving 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 interventionNasal 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 interventionNasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
Efficacy in eradicating Staphylococcus aureus (SA)
The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.
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