Reducing Perioperative S. Aureus Transmission Via OR PathTrac

NCT04657185 | Completed

• 1 other identifier: 00000375
• Study Type: observational
• Target: 804
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.

Conditions

S. Aureus Transmission; Surgical Site Infection

Keywords

transmission; surgical site infection; s. aureus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• surgical site infection

  Up to 90 days following surgery

Study Arms (2)

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

Interventions

OR PathTrac Feedback Optimization OTHER

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.

After OR PathTrac Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing surgery requiring anesthesia and intravascular access.

You may qualify if:

• Adult patients requiring anesthesia and intravenous catheter placement.

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead
• RDB Bioinformatics: collaborator
• University of Iowa: collaborator
• Trustees of Dartmouth College: collaborator

Study Sites (1)

Georgetown University

Georgetown, District of Columbia, 20057, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

S. aureus pathogens collected were assigned a unique identification number and stored for future analysis.

MeSH Terms

Conditions

Surgical Wound Infection; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: July 15, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: One year after publication the data will become available and will remain available for one year.
• Access Criteria: Submission of a research proposal to be reviewed by Dr. Wall.

Locations

US (1)