OR PathTrac (Tracking Intra-operative Bacterial Transmission)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03605498

Enrollment

Registered

2018-07-30

Start date

2017-09-05

Completion date

2018-02-12

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 105 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results