Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT07242560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidural Catheter and Port-Related Infections in Pain Clinic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 351}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Infection Associated With Epidural Catheter or Port Use', 'timeFrame': 'From date of catheter or port placement until device removal or completion of follow-up (within study period January 2002-January 2025).', 'description': 'The proportion of patients who developed infection following epidural catheter or port placement, confirmed either clinically or microbiologically (positive culture from catheter tip or port site).'}], 'secondaryOutcomes': [{'measure': 'Risk Factors Associated With Infection Development', 'timeFrame': 'Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).', 'description': 'Evaluation of demographic and procedural variables (e.g., catheter duration, insertion site, indication, comorbidities) and their association with infection occurrence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural catheter', 'Epidural port', 'Infection', 'Pain clinic', 'Interventional pain management'], 'conditions': ['Epidural Catheter-Related Infection', 'Hospital-Acquired Infection', 'Procedural Complication']}, 'referencesModule': {'references': [{'pmid': '18831298', 'type': 'BACKGROUND', 'citation': 'Horlocker TT, Wedel DJ. Infectious complications of regional anesthesia. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):451-75. doi: 10.1016/j.bpa.2008.06.003.'}, {'pmid': '39588402', 'type': 'BACKGROUND', 'citation': 'Domingues C, Goncalves L, Laranjo M, Santos T, Goncalves D, Goncalves L, Barros AC, Marrao G, Castro R, Valente E. Epidural Catheter Bacterial Colonization and Infection in a Secondary Portuguese Hospital Setting. Cureus. 2024 Oct 26;16(10):e72428. doi: 10.7759/cureus.72428. eCollection 2024 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective observational study aims to evaluate the incidence and risk factors of infection associated with epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine. Data from patients who underwent epidural catheter or port placement between January 2002 and January 2025 will be analyzed.\n\nDemographic data, catheter duration, insertion level, type of device, clinical indication, and microbiological culture results will be examined to determine factors influencing infection development. The study seeks to identify common pathogens and assess potential relationships between procedural characteristics and infection risk.\n\nThe ultimate goal of this research is to contribute to improving infection prevention strategies and ensuring patient safety in interventional pain management practices.', 'detailedDescription': 'This retrospective cohort study investigates the factors associated with infection development following epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine between January 2002 and January 2022. Data collection has been completed, and the final data analysis is expected to be finalized by November 30, 2025.\n\nEpidural catheterization and port placement are frequently performed interventional pain management procedures used for postoperative and chronic cancer pain treatment. Despite their clinical utility, these procedures carry a risk of infection that can lead to serious complications, including epidural abscess, meningitis, or systemic sepsis.\n\nThe study retrospectively reviews 351 cases from institutional archives. Demographic data (age, sex, diagnosis), procedural details (catheter duration, insertion level, anatomical site, indication, brand), and infection outcomes (presence of infection, culture results, and isolated microorganisms) are analyzed.\n\nPrimary outcome is the incidence of infection associated with epidural catheter or port use. Secondary outcomes include identifying risk factors such as catheter duration, insertion site, clinical indication, and the distribution of isolated pathogens. Statistical analyses are conducted using appropriate parametric or non-parametric tests, and p \\< 0.05 is considered significant.\n\nThe findings of this study are expected to contribute to improving infection prevention strategies and clinical protocols for safer interventional pain management practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at the Pain Clinic of Mersin University Faculty of Medicine who received epidural catheter or port applications for pain management between 2002 and 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and older.\n* Patients who underwent epidural catheter or epidural port application at Mersin University Pain Clinic between January 1, 2002 and January 1, 2025.\n* Complete clinical records including demographic data, procedural details, and culture results available for review.\n\nExclusion Criteria:\n\n* Patients with incomplete or missing procedural or infection data.\n\nPatients whose records do not include culture or infection status documentation.\n\nPatients younger than 18 years old.'}, 'identificationModule': {'nctId': 'NCT07242560', 'briefTitle': 'Epidural Catheter and Port-Related Infections in Pain Clinic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Factors Associated With Infection Development in Epidural Catheter and Port Applications in a University Pain Clinic: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'Mersin-ALG-ECPI-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidural Catheter Group', 'description': 'Patients who underwent epidural catheter insertion for pain management between January 2002 and December 2022 at the Mersin University Pain Clinic. Data include catheter duration, insertion site, indication, and culture results.'}, {'label': 'Epidural Port Group', 'description': 'Patients who received epidural port placement for long-term analgesic management during the same period. Data include port type, indication, duration of use, and infection outcomes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33110', 'city': 'Mersin', 'state': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University Faculty of Medicine, Department of Algology', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Mesut Bakır, Assoc. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mersin University Faculty of Medicine, Pain Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a retrospective study based on de-identified patient records. No individual participant data (IPD) will be shared. Only aggregated results may be published in scientific journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mesut Bakır', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr. Mesut Bakır, Mersin University Faculty of Medicine, Department of Algology', 'investigatorFullName': 'Mesut Bakır', 'investigatorAffiliation': 'Mersin University'}}}}