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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04865003
Other study ID # 1208983
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2020

Study information

Verified date April 2021
Source Clinical Center of Vojvodina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients admitted to the hospital due to deep neck infection affecting two or more spaces with or without descending necrotizing medioastinitis - complete diagnosis and treatment data available from medical charts Exclusion Criteria: - incomplete medical data - infection confined to one deep neck space - patients treated under local anesthesia - patients with superficial skin infections - iatrogenic infections - infected tumors

Study Design


Intervention

Other:
treatment of infection


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Clinical Center of Vojvodina

References & Publications (5)

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. — View 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. — View Citation

Prado-Calleros HM, Jiménez-Fuentes E, Jiménez-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 20 — View 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.j — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of mediastinitis Neck and chest computed tomography (CT) Within 6 hours of admission
Secondary Microbiological findings in DNI and DNM Prevalence of microorganisms in mediastinitis Within 1 week of admission
Secondary Average number of hospital days Comparison of average number of hospital days in DNI and DNM Through study completion, an average of one month
Secondary Incidence of complications Complications among DNI and DNI+DNM groups Within 30 days from admission
Secondary Number of infected deep neck spaces Neck and chest computed tomography (CT) Within 6 hours of admission
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