OR PathTrac (Tracking Intra-operative Bacterial Transmission)

Study Overview
=================
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.

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

Conditions
-----------------
Bacterial Infections

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify transmission dynamics of pathogenic bacteria (i.e. Staph aureus). | 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. | 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). | 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. | 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. | 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 |