Reducing Perioperative S. Aureus Transmission Via OR PathTrac

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657185
• Other study ID #: 00000375
• Status: Completed
• Start date: July 15, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: December 2020
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients requiring anesthesia and intravenous catheter placement.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• S. Aureus Transmission
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University	Georgetown	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Georgetown University	RDB Bioinformatics, Trustees of Dartmouth College, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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