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OpenTrials
Completed

NCT Number: NCT03605498

OR PathTrac (Tracking Intra-operative Bacterial Transmission)

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sundara Reddy

Other

Collaborators

  • B. Braun Medical Inc.
  • RDB Bioinformatics

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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