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CompletedNCT04657185Updated Sep 11, 2025

Reducing Perioperative S. Aureus Transmission Via OR PathTrac

An observational study in S. Aureus Transmission and Surgical Site Infection, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Georgetown University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
804
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • S. Aureus Transmission
  • Surgical Site Infection

Keywords

  • transmission
  • surgical site infection
  • s. aureus
03

In context

Surgical Wound Infection

670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.

This study's enrollment of 804 is above the median of 237 across 128 observational studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients undergoing surgery requiring anesthesia and intravascular access.

Inclusion criteria

  • Adult patients requiring anesthesia and intravenous catheter placement.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
804 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherOR 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.

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What researchers measure

Primary outcomes

  1. within-case S. aureus transmission

    S. aureus transmission events detected within a surgical case

    Time frame: From patient entry into the operating room until case end, up to 6 hours

Secondary outcomes

  1. surgical site infection

    evidence of infection (office note documentation with anti-infective order and/or isolation of one or more potentially pathogenic organisms

    Time frame: Up to 90 days following surgery

07

Study locations

1 site
  • Georgetown University
    Georgetown, District of Columbia 20057, United States
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References and documents

Individual participant data

Plan to share: Yes — Other researchers must submit a research proposal to be reviewed by Dr. Wall for determination of release.

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04657185
Lead sponsor
Georgetown University
Collaborators
RDB Bioinformatics, University of Iowa, Trustees of Dartmouth College
Responsible party
Sponsor
First posted
Dec 8, 2020
Start date
Jul 15, 2019
Primary completion
Mar 20, 2020
Completion
Mar 20, 2020
Last update
Sep 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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