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OR PathTrac (Tracking Intra-operative Bacterial Transmission)

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ClinicalTrials.gov Identifier: NCT03605498
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
B. Braun Medical Inc.
RDB Bioinformatics, LLC
Information provided by (Responsible Party):
Sundara Reddy, University of Iowa

Tracking Information
First Submitted Date June 8, 2018
First Posted Date July 30, 2018
Last Update Posted Date March 1, 2019
Actual Study Start Date September 5, 2017
Actual Primary Completion Date February 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2018)
  • 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 clonal transmission of Staph aureus. [ Time Frame: 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). [ 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03605498 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 20, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The bacterial cultures can be kept and analyzed at a later date to determine how they have transformed into antibiotic resistant organisms.
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.
Condition Bacterial Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2018)
83
Original Actual Enrollment Same as current
Actual Study Completion Date February 12, 2018
Actual Primary Completion Date February 12, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 105 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03605498
Other Study ID Numbers 201705826
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
Responsible Party Sundara Reddy, University of Iowa
Study Sponsor Sundara Reddy
Collaborators
  • B. Braun Medical Inc.
  • RDB Bioinformatics, LLC
Investigators
Principal Investigator: Sundara Reddy, MBBS, FRCA University of Iowa
PRS Account University of Iowa
Verification Date February 2019