Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-10 @ 9:41 PM
Study NCT ID:
NCT07130656
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI Algorithm for Surveillance of Deep Surgical Site Infections After Elective Colorectal Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of surgical site infection', 'timeFrame': '30 days', 'description': 'Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Site Infection', 'Surveillance', 'Articicial inteligence', 'Algorithms'], 'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': '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).\n\nAt 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.\n\nThe 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.', 'detailedDescription': '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.\n\nEpidemiological 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.\n\nFor 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.\n\nAt 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.\n\nThe 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.\n\nThe aim of this study was to evaluate the performance of a novel algorithm to detect to detect SSI at its three anatomical levels, in a cohort of elective colorectal surgery patients who have been previously screened within a nationwide healthcare-associated infection surveillance system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective colorectal surgery in Hospital General de Granollers in the period 2010-2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective colorectal resection\n\nExclusion Criteria:\n\n* Emergency surgery\n* Infection present at operation\n* Previous intestinal stoma'}, 'identificationModule': {'nctId': 'NCT07130656', 'acronym': 'Infect-IA-2', 'briefTitle': 'AI Algorithm for Surveillance of Deep Surgical Site Infections After Elective Colorectal Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Granollers'}, 'officialTitle': 'A Novel AI Algorithm With Enhanced Accuracy for Surveillance of Deep Surgical Site Infections After Elective Colorectal Surgery. A Diagnostic Accuracy Study.', 'orgStudyIdInfo': {'id': 'Infect-IA-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients assessed for SSI using the standard manual surveillance method', 'description': 'Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the standard manual surveillance method.', 'interventionNames': ['Diagnostic Test: Diagnosis of SSI']}, {'label': 'Patients assessed for SSI by an algorithm', 'description': 'Patients undergoing colorectal surgery enrolled in the nationwide SSI surveillance programme and assessed for SSI using the new algorithm', 'interventionNames': ['Diagnostic Test: Diagnosis of SSI']}], 'interventions': [{'name': 'Diagnosis of SSI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnosis of SSI by manual system in colorectal surgery procedures enrolled in the SSI surveillance programme.', 'armGroupLabels': ['Patients assessed for SSI by an algorithm', 'Patients assessed for SSI using the standard manual surveillance method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08402', 'city': 'Granollers', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Josep M Badia', 'role': 'CONTACT', 'email': 'jmbadiaperez@gmail.com', 'phone': '670702099'}], 'facility': 'Hospital General de Granollers', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}], 'centralContacts': [{'name': 'Josep M Badia, MD, PhD', 'role': 'CONTACT', 'email': 'jmbadiaperez@gmail.com', 'phone': '670702099'}], 'overallOfficials': [{'name': 'Diana Navarro, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital General de Granollers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Granollers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Josep M Badia', 'investigatorAffiliation': 'Hospital de Granollers'}}}}