Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 4:11 AM
Study NCT ID:
NCT04865003
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D008480', 'term': 'Mediastinitis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D008477', 'term': 'Mediastinal Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of mediastinitis', 'timeFrame': 'Within 6 hours of admission', 'description': 'Neck and chest computed tomography (CT)'}], 'secondaryOutcomes': [{'measure': 'Microbiological findings in DNI and DNM', 'timeFrame': 'Within 1 week of admission', 'description': 'Prevalence of microorganisms in mediastinitis'}, {'measure': 'Average number of hospital days', 'timeFrame': 'Through study completion, an average of one month', 'description': 'Comparison of average number of hospital days in DNI and DNM'}, {'measure': 'Incidence of complications', 'timeFrame': 'Within 30 days from admission', 'description': 'Complications among DNI and DNI+DNM groups'}, {'measure': 'Number of infected deep neck spaces', 'timeFrame': 'Within 6 hours of admission', 'description': 'Neck and chest computed tomography (CT)'}]}, 'conditionsModule': {'conditions': ['Infection', 'Mediastinitis', 'Neck Abscess', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '26829352', 'type': 'RESULT', 'citation': 'Prado-Calleros HM, Jimenez-Fuentes E, Jimenez-Escobar I. Descending necrotizing mediastinitis: Systematic review on its treatment in the last 6 years, 75 years after its description. Head Neck. 2016 Apr;38 Suppl 1:E2275-83. doi: 10.1002/hed.24183. Epub 2016 Feb 1.'}, {'pmid': '31862339', 'type': 'RESULT', 'citation': 'Qu L, Xu H, Liang X, Cai X, Zhang W, Qian W. A Retrospective Cohort Study of Risk Factors for Descending Necrotizing Mediastinitis Caused by Multispace Infection in the Maxillofacial Region. J Oral Maxillofac Surg. 2020 Mar;78(3):386-393. doi: 10.1016/j.joms.2019.11.017. Epub 2019 Nov 26.'}, {'pmid': '21820786', 'type': 'RESULT', 'citation': 'Sarna T, Sengupta T, Miloro M, Kolokythas A. Cervical necrotizing fasciitis with descending mediastinitis: literature review and case report. J Oral Maxillofac Surg. 2012 Jun;70(6):1342-50. doi: 10.1016/j.joms.2011.05.007. Epub 2011 Aug 6.'}, {'pmid': '18952475', 'type': 'RESULT', 'citation': 'Boscolo-Rizzo P, Da Mosto MC. Submandibular space infection: a potentially lethal infection. Int J Infect Dis. 2009 May;13(3):327-33. doi: 10.1016/j.ijid.2008.07.007. Epub 2008 Oct 25.'}, {'pmid': '31747058', 'type': 'RESULT', 'citation': 'Kimura A, Miyamoto S, Yamashita T. Clinical predictors of descending necrotizing mediastinitis after deep neck infections. Laryngoscope. 2020 Nov;130(11):E567-E572. doi: 10.1002/lary.28406. Epub 2019 Nov 20.'}, {'pmid': '34542654', 'type': 'DERIVED', 'citation': 'Brajkovic D, Zjalic S, Kiralj A. Prognostic factors for descending necrotizing mediastinitis development in deep space neck infections-a retrospective study. Eur Arch Otorhinolaryngol. 2022 May;279(5):2641-2649. doi: 10.1007/s00405-021-07081-0. Epub 2021 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'Descending necrotizing mediastinitis (DNM) is the most serious complication of deep neck infections (DNI) with high mortality. The objective of this retrospective study was to evaluate possible prognostic factors for DNM development in deep space neck infections.', 'detailedDescription': 'Descending necrotizing mediastinitis (DNM) is the most serious complication of deep neck infections (DNI) with high mortality. The objective of this retrospective study was to evaluate possible prognostic factors for DNM development in deep space neck infections. The study enrolled patients admitted to the Emergency Center of Vojvodina with the diagnosis of multispace DNI with or without DNM either as the primary diagnosis or with discharged diagnosis after surgical treatment during 7-years period. The data were obtained from patient medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study enrolled patients admitted to the Emergency Center of Vojvodina with the diagnosis of multispace DNI with or without DNM either as the primary diagnosis or with discharged diagnosis after surgical treatment.\n\nThe diagnosis of DNM was based on standard Estrera et al. diagnostic criteria. Cases included in the study comprised patients admitted to the hospital due to DNI affecting two or more spaces with or without DNM. Cases were excluded from the study if complete medical data could not be obtained from medical charts.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to the hospital due to deep neck infection affecting two or more spaces with or without descending necrotizing medioastinitis\n* complete diagnosis and treatment data available from medical charts\n\nExclusion Criteria:\n\n* incomplete medical data\n* infection confined to one deep neck space\n* patients treated under local anesthesia\n* patients with superficial skin infections\n* iatrogenic infections\n* infected tumors'}, 'identificationModule': {'nctId': 'NCT04865003', 'briefTitle': 'Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Center of Vojvodina'}, 'officialTitle': 'Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections - A Retrospective Study', 'orgStudyIdInfo': {'id': '1208983'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DNI group', 'description': 'patients with infection of two or more deep neck spaces (DNI group)', 'interventionNames': ['Other: treatment of infection']}, {'label': 'DNI + DNM group', 'description': 'patients with infection of two or more deep neck spaces with secondary descending necrotizing mediastinitis (DNI + DNM group)', 'interventionNames': ['Other: treatment of infection']}], 'interventions': [{'name': 'treatment of infection', 'type': 'OTHER', 'armGroupLabels': ['DNI + DNM group', 'DNI group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aleksandar Kiralj, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Center of Vojvodina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Center of Vojvodina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Denis Brajković', 'investigatorAffiliation': 'Clinical Center of Vojvodina'}}}}