Clinical trial NCT04299737: Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections
Official title: Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: S. Aureus Transmission
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: RDB Bioinformatics
First posted: 2020-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.

Brief summary: The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Detailed description: Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery.

Patients undergoing planned oncologic gynecological and plastic surgery will be entered as dyads into a worksheet each day that will rank and select the optimal cases. The research assistants consent both patients in the dyad to the study while they are in the Day of Surgery Admissions area. The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac kits are obtained from and analyzed for S. aureus isolates by RDB Bioinformatics. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
* informed, written consent.

Exclusion Criteria:

* Patients \<18 years of age.
* Patients scheduled to undergo procedures outside of the surgical service lines listed above.
* Patients not requiring general or regional anesthesia.
* Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine.
* Patients who have not provided informed, written consent.

Primary outcomes:
measure: Time course in S. aureus transmission decline with the intervention.
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Randy W Loftus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial transmission. Anesth Analg. 2012 Jun;114(6):1236-48. doi: 10.1213/ANE.0b013e31824970a2. Epub 2012 Mar 30.
citation: Dexter F, Ledolter J, Epstein RH, Loftus RW. Importance of operating room case scheduling on analyses of observed reductions in surgical site infections from the purchase and installation of capital equipment in operating rooms. Am J Infect Control. 2020 May;48(5):566-572. doi: 10.1016/j.ajic.2019.08.017. Epub 2019 Oct 19.
citation: Dexter F, Epstein RH, Gostine AL, Penning DH, Loftus RW. Benefit of systematic selection of pairs of cases matched by surgical specialty for surveillance of bacterial transmission in operating rooms. Am J Infect Control. 2020 Jun;48(6):682-687. doi: 10.1016/j.ajic.2019.09.025. Epub 2019 Nov 1.
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citation: Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.
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