Reducing ESKAPE Transmission in the Operating Room

February 15, 2024 updated by: Andrew Pugely, University of Iowa

Reducing Intraoperative ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter Spp.) Transmission Via Use of an Evidence-Based, Hand Hygiene Program Optimized by OR PathTrac

This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A solid body of published and preliminary evidence leveraging systematic phenotypic and whole cell genome analysis and innovative surveillance technology has provided great insight into the epidemiology of perioperative bacterial transmission and healthcare-associated infection (HAI) development. This work has led us to three primary assertions that serve as the foundation of our scientific premise: 1) Further progress towards HAI prevention is needed, 2) Prevention of perioperative ESKAPE transmission is an important improvement target, and 3) An evidence-based, multi-faceted program can reduce perioperative ESKAPE transmission. Further work to generate intraoperative hand hygiene improvement is indicated. We hypothesize that the proposed program will generate sustained reductions in OR ESKAPE exposure and S. aureus transmission that will lead to sustained reductions in perioperative HAIs.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Randy W Loftus, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult patients undergoing surgery requiring general anesthesia and intravascular access.

Description

Inclusion Criteria: Adult patients undergoing surgery requiring general anesthesia and peripheral IV and/or central line placement.

Exclusion Criteria:

Pediatric patient, not requiring general anesthesia and/or IV/central line placement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Usual care
Patients undergoing surgery requiring general anesthesia. Usual hand hygiene devices and products will be accessible which will include but are not limited to those mounted to the wall outside of the operating room entrance and those present on the anesthesia cart.
Personalized body worn alcohol dispenser
Anesthesia providers (attending anesthesiologist and their assistant (resident physician/Certified-Registered Nurse Anesthetist (CRNA), or student nurse assistant (SRNA) will receive a personalized, body worn alcohol dispenser in addition to usual hand hygiene devices/products for hand decontamination during surgery requiring general anesthesia.
Device: Personalized Body-Worn Alcohol Dispenser
This is an alcohol dispenser that will be worn on the Anesthesia Providers scrub pants, near the hip. It will be worn by both the attending physician and the resident physician/CRNA/SRNA. The device is produced by Georgia-Pacific.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ESKAPE transmission events with and without the body worn device
Time Frame: Up to 96 hours from the surgial procedure
Reduce the number of Enterococcus, Staphylococcus aureus, Pseudomonas, and other gram-negative (i.e., Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events
Up to 96 hours from the surgial procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The epidemiology of ESKAPE transmission events
Time Frame: Up to 90 days from surgery
To characterize the epidemiology of ESKAPE transmission with and without the device according to incidence.
Up to 90 days from surgery
The epidemiology of ESKAPE transmission events
Time Frame: Up to 90 days from surgery
To characterize the epidemiology of ESKAPE transmission with and without the device according to reservoir of origin.
Up to 90 days from surgery
The epidemiology of ESKAPE transmission events
Time Frame: Up to 90 days from surgery
To characterize the epidemiology of ESKAPE transmission with and without the device according to transmission location(s).
Up to 90 days from surgery
The epidemiology of ESKAPE transmission events
Time Frame: Up to 90 days from surgery
To characterize the epidemiology of ESKAPE transmission with and without the device according to portal of entry (stopcock).
Up to 90 days from surgery
The epidemiology of ESKAPE transmission events
Time Frame: Up to 90 days from surgery
To characterize the epidemiology of ESKAPE transmission with and without the device according to mode (within or between-case).
Up to 90 days from surgery
90-Day Healthcare-Associated Infections
Time Frame: 90 days following surgery
Number of infections occurring within 90 days of surgery
90 days following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

RDB Bioinformatics, LLC
Georgia-Pacific

Investigators

  • Principal Investigator: Andrew Pugely, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 202111418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data requests submitted to the PI will be reviewed and considered.

IPD Sharing Time Frame

1 year from the final study completion date (earliest date) and up to an additional 24 months.

IPD Sharing Access Criteria

A sumitted proposal that is reviewed and approved by the PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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