OR PathTrac (Tracking Intra-operative Bacterial Transmission)

NCT ID: NCT03605498

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2018-02-12

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.

Conditions

Bacterial Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

B. Braun Medical Inc.

INDUSTRY

Sponsor Role: collaborator

RDB Bioinformatics

INDUSTRY

Sponsor Role: collaborator

Sundara Reddy

OTHER

Sponsor Role: lead

Responsible Party

Sundara Reddy

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sundara Reddy, MBBS, FRCA

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

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Other Identifiers

201705826

Identifier Type: -

Identifier Source: org_study_id