Reducing Perioperative S. Aureus Transmission Via OR PathTrac

Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR PathTrac)

Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly pathogenic. Isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). This project involves implementation of a software platform and bacterial collection system (OR PathTrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. We will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; S. Aureus Transmission
• Intervention / Treatment: Other: OR PathTrac Feedback Optimization

Detailed Description

Our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on S. aureus transmission and SSIs. A multifaceted infection control program was implemented over 8 months (November 2018 to June 2019). A prospective cohort impact study was then conducted over 8 months (July 2019 to March 2020) to compare the incidence of within-case S. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.

• Study Type: Observational
• Enrollment (Actual): 804

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Georgetown, District of Columbia, United States, 20057
      • Georgetown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing surgery requiring anesthesia and intravascular access.

Description

Inclusion Criteria:

• Adult patients requiring anesthesia and intravenous catheter placement.

Exclusion Criteria:

• Pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before OR PathTrac Feedback; Patients undergoing surgery with an evidence-based, multifaceted, perioperative infection control program in place but without OR PathTrac feedback optimization.
After OR PathTrac Feedback; Patients undergoing surgery with an evidence-based, multifaceted, perioperative infection control program in place AND OR PathTrac feedback optimization.	Other: OR PathTrac Feedback Optimization; OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) uses a systematic phenotypic approach leveraging temporal association to monitor 13 anesthesia work area reservoirs proven to be associated with high-risk intraoperative bacterial transmission events and subsequent infection development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
within-case S. aureus transmission	S. aureus transmission events detected within a surgical case	From patient entry into the operating room until case end, up to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical site infection	evidence of infection (office note documentation with anti-infective order and/or isolation of one or more potentially pathogenic organisms	Up to 90 days following surgery

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: University of Iowa; Trustees of Dartmouth College; RDB Bioinformatics

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: surgical site infection; transmission; s. aureus
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: 00000375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Other researchers must submit a research proposal to be reviewed by Dr. Wall for determination of release.
• IPD Sharing Time Frame: One year after publication the data will become available and will remain available for one year.
• IPD Sharing Access Criteria: Submission of a research proposal to be reviewed by Dr. Wall.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No