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Clinical Trials/NCT07130656
NCT07130656RecruitingNot Applicable

A Novel AI Algorithm With Enhanced Accuracy for Surveillance of Deep Surgical Site Infections After Elective Colorectal Surgery. A Diagnostic Accuracy Study.

Hospital de Granollers1 site in 1 country1,200 target enrollmentStarted: January 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,200
Locations
1
Primary Endpoint
Rate of surgical site infection

Study Overview

Brief Summary

Epidemiological surveillance is one of the eight core components of the World Health Organization Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI).

At present, for SSI surveillance, infection control teams perform a manual time-consuming work, which could make a transition to automated surveillance leveraging the new information technology.

The aim of this study was to evaluate the performance of a novel algorithm to detect SSI in a cohort of elective colorectal surgery patients who have been previously screened within a nationwide healthcare-associated infection surveillance system.

Detailed Description

Healthcare-associated infections (HAIs) have a negative impact on patient health, represent a significant healthcare and economic burden on healthcare systems and are considered the most preventable cause of serious adverse events in hospitalised patients.

Epidemiological surveillance is one of the eight core components of the World Health Organization (WHO) Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI), which have proven to be effective in all types of surgery and in a variety of settings.

For a programme to be effective, surveillance for HCAIs must be active, prospective and continuous, comprising a surveillance period up to 30-90 days post-intervention, to cover the high rate of SSIs detected after discharge.

At present, infection control teams perform a manual, prospective, time-consuming and almost artisanal work, which should make a transition to automated or semi-automated surveillance that leverages the possibilities offered by today's information technology.

The evolution of surveillance systems should benefit from this new possibilities offered by artificial intelligence, allowing automated detection of suspected SSI adverse events from clinical course text, microbiology reports or coding of diagnoses, procedures, complications and readmissions.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Elective colorectal resection

Exclusion Criteria

  • •Emergency surgery
  • •Infection present at operation
  • •Previous intestinal stoma

Outcomes

Primary Outcomes

Rate of surgical site infection

Time Frame: 30 days

Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital de Granollers
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Josep M Badia

Prof

Hospital de Granollers

Study Sites (1)

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