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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04657185
Other study ID # 00000375
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date March 20, 2020

Study information

Verified date December 2020
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Healthcare-associated infections (HAIs) occur frequently and are associated with patient harm. It is important that healthcare facilities take the necessary steps to prevent the spread of resistant bacteria. ESKAPE bacteria (Enterococcus, S. aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly pathogenic. Isolation of these pathogens from intraoperative reservoirs has been associated with postoperative infection development (i.e. surgical site infections). This project involves implementation of a software platform and bacterial collection system (OR PathTrac) that leverages the epidemiology of intraoperative bacterial transmission to guide dynamic, prospective improvements in perioperative infection control measures. We will assess the effectiveness of OR PathTrac feedback in optimizing an evidence-based, multifaceted, perioperative infection control program.


Description:

Our objective was to analyze the impact of surveillance feedback optimization of a multifaceted, perioperative infection control program on S. aureus transmission and SSIs. A multifaceted infection control program was implemented over 8 months (November 2018 to June 2019). A prospective cohort impact study was then conducted over 8 months (July 2019 to March 2020) to compare the incidence of within-case S. aureus transmission (primary outcome) and surgical site infection (secondary outcome) before (4.5 months) and after (3.5 months) implementation of surveillance feedback.


Recruitment information / eligibility

Status Completed
Enrollment 804
Est. completion date March 20, 2020
Est. primary completion date March 20, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients requiring anesthesia and intravenous catheter placement. Exclusion Criteria: - Pediatric patients, without requirement of anesthesia and/or intravenous catheter placement.

Study Design


Intervention

Other:
OR PathTrac Feedback Optimization
OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) uses a systematic phenotypic approach leveraging temporal association to monitor 13 anesthesia work area reservoirs proven to be associated with high-risk intraoperative bacterial transmission events and subsequent infection development.

Locations

Country Name City State
United States Georgetown University Georgetown District of Columbia

Sponsors (4)

Lead Sponsor Collaborator
Georgetown University RDB Bioinformatics, Trustees of Dartmouth College, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary within-case S. aureus transmission S. aureus transmission events detected within a surgical case From patient entry into the operating room until case end, up to 6 hours
Secondary surgical site infection evidence of infection (office note documentation with anti-infective order and/or isolation of one or more potentially pathogenic organisms Up to 90 days following surgery
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