OR PathTrac (Tracking Intra-operative Bacterial Transmission)

February 28, 2019 updated by: Sundara Reddy

An Investigation of Novel Technology to Bring Genomic Analysis to the Patient Bedside to Systematically Track and Report on ESKAPE Bacterial Transmission in Today's Operating Room Environments

Healthcare-associated infections occur frequently and are associated with patient harm. These infections are becoming more difficult to treat due to antibiotic resistance. It is important that healthcare facilities take the steps necessary to prevent the spread of resistant bacteria between patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Two patients undergoing sedation in a randomly selected operating room will be evaluated in a serial manner in order to detect transmission of pathogenic bacteria. Patient care will not change due to their participation in this study; the patients will undergo sedation and surgery according to usual practice. This study involves taking microbiology cultures from various places in the operating room before and after each procedure. Cultures will also be taken from the two patients after they are asleep and from their intravenous tubing. From both patients anesthesiologist, surgeon and their surgical team, cRNA, and nursing staff will also have cultures obtained. Each cultures will be de-identified and given a study ID number before transport to the research laboratory for microbiological assay. The patient's medical record will be reviewed for 30 days after surgery to surveil for documentation of a potential hospital acquired infection.

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

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

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics

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

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be surgical patients requiring peripheral intravenous and/or central venous catheter access and undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.

Description

Inclusion Criteria:

  • At least 18 years of age
  • Require peripheral intravenous and/or central venous catheter placement
  • Undergoing gynecology/oncology, colorectal, open vascular, total joint or cardiovascular procedures.

Exclusion Criteria:

  • Less than 18 years of age
  • Does not require peripheral intravenous and/or central venous catheter placement
  • Patient refusal to participate
  • Incarceration

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus).
Time Frame: Intraoperative period
Focus on how Staph aureus is transmitted in the operating room by identifying key areas of origin.
Intraoperative period
Intraoperative clonal transmission of Staph aureus.
Time Frame: Intraoperative period
Monitor locations throughout the operating room to document clonal transmission from the area of origin.
Intraoperative period
Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus).
Time Frame: Intraoperative period
If transmission of Staph aureus from the site of origin to another site in the operating room arena is documented, identify the modes of transmission.
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitor for post operative healthcare associated infections.
Time Frame: Up to 30 days following surgery
Monitor for the presence or absence of healthcare associated infection after undergoing an operative procedure.
Up to 30 days following surgery
Surveil for molecular links between pathogenic organisms.
Time Frame: Up to 30 days following surgery
Seek to identify molecular links between causative organisms of infection and bacteria found in the operating room at the time of surgery.
Up to 30 days following surgery

Collaborators and Investigators

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

Sponsor

Sundara Reddy

Collaborators

B. Braun Medical Inc.
RDB Bioinformatics, LLC

Investigators

  • Principal Investigator: Sundara Reddy, MBBS, FRCA, 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

Helpful Links

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)

September 5, 2017

Primary Completion (Actual)

February 12, 2018

Study Completion (Actual)

February 12, 2018

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201705826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Time Frame

IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Access Criteria

IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

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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