NCT07130656

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 12, 2025

Last Update Submit

August 19, 2025

Conditions

Keywords

Surgical Site InfectionSurveillanceArticicial inteligenceAlgorithms

Outcome Measures

Primary Outcomes (1)

  • Rate of surgical site infection

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

    30 days

Study Arms (2)

Patients assessed for SSI using the standard manual surveillance method

Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the standard manual surveillance method.

Diagnostic Test: Diagnosis of SSI

Patients assessed for SSI by an algorithm

Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the new algorithm

Diagnostic Test: Diagnosis of SSI

Interventions

Diagnosis of SSIDIAGNOSTIC_TEST

Diagnosis of SSI by manual system in colorectal surgery procedures enrolled in the SSI surveillance programme.

Patients assessed for SSI by an algorithmPatients assessed for SSI using the standard manual surveillance method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective colorectal surgery in Hospital General de Granollers in the period 2010-2023

You may qualify if:

  • Elective colorectal resection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

RECRUITING

Related Publications (1)

  • Casanova-Portoles D, Badia JM, Forero CG, Sanchez-Martinez N, Romero M, Alonso-Solis T, Limon E, Pujol M, Sancho J. A structured-data algorithm for semiautomated surveillance of surgical site infection after colorectal surgery: A diagnostic accuracy study. J Infect Public Health. 2026 Jan 15;19(4):103151. doi: 10.1016/j.jiph.2026.103151. Online ahead of print.

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diana Navarro, PhD

    Hospital General de Granollers

    STUDY CHAIR

Central Study Contacts

Josep M Badia, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

January 15, 2025

Primary Completion

August 30, 2025

Study Completion

October 30, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations