OR PathTrac (Tracking Intra-operative Bacterial Transmission)

Sponsor

Sundara Reddy (Other)

Overall Status

Completed

CT.gov ID

NCT03605498

Collaborator

B. Braun Medical Inc. (Industry), RDB Bioinformatics, LLC (Other)

Enrollment

Location

5.3

Actual Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections

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 Design

Study Type:

Observational

Actual Enrollment :

83 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 5, 2017

Actual Primary Completion Date :

Feb 12, 2018

Actual Study Completion Date :

Feb 12, 2018

Outcome Measures

Primary Outcome Measures

Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus). [Intraoperative period]
Focus on how Staph aureus is transmitted in the operating room by identifying key areas of origin.
Intraoperative clonal transmission of Staph aureus. [Intraoperative period]
Monitor locations throughout the operating room to document clonal transmission from the area of origin.
Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus). [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.

Secondary Outcome Measures

Monitor for post operative healthcare associated infections. [Up to 30 days following surgery]
Monitor for the presence or absence of healthcare associated infection after undergoing an operative procedure.
Surveil for molecular links between pathogenic organisms. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

Sundara Reddy
B. Braun Medical Inc.
RDB Bioinformatics, LLC

Investigators

Principal Investigator: Sundara Reddy, MBBS, FRCA, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Sundara Reddy, Clinical Associate Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT03605498

Other Study ID Numbers:

201705826

First Posted:

Jul 30, 2018

Last Update Posted:

Mar 1, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bacterial Infections

Study Results

No Results Posted as of Mar 1, 2019