Clinical trial NCT03605498: OR PathTrac (Tracking Intra-operative Bacterial Transmission)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: B. Braun Medical Inc.
name: RDB Bioinformatics
First posted: 2018-07-30
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus).
timeFrame: Intraoperative period
measure: Intraoperative clonal transmission of Staph aureus.
timeFrame: Intraoperative period
measure: Identify the modes of transmission of pathogenic bacteria ((i.e. Staph aureus).
timeFrame: Intraoperative period
Secondary outcomes:
measure: Monitor for post operative healthcare associated infections.
timeFrame: Up to 30 days following surgery
measure: Surveil for molecular links between pathogenic organisms.
timeFrame: Up to 30 days following surgery
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Sundara Reddy, MBBS, FRCA
role: PRINCIPAL_INVESTIGATOR
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