Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections

NCT04865003 | Completed

• 1 other identifier: 1208983
• Study Type: observational
• Target: 289
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Infection; Mediastinitis; Neck Abscess; Inflammation

Outcome Measures

Primary Outcomes (1)

• Incidence of mediastinitis

  Neck and chest computed tomography (CT)

  Within 6 hours of admission

Secondary Outcomes (4)

• Microbiological findings in DNI and DNM

  Within 1 week of admission

• Average number of hospital days

  Through study completion, an average of one month

• Incidence of complications

  Within 30 days from admission

• Number of infected deep neck spaces

  Within 6 hours of admission

Study Arms (2)

DNI group

patients with infection of two or more deep neck spaces (DNI group)

Other: treatment of infection

DNI + DNM group

patients with infection of two or more deep neck spaces with secondary descending necrotizing mediastinitis (DNI + DNM group)

Other: treatment of infection

Interventions

treatment of infection OTHER

DNI + DNM group; DNI group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. The 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.

You may qualify if:

• 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

You may not qualify if:

• incomplete medical data
• infection confined to one deep neck space
• patients treated under local anesthesia
• patients with superficial skin infections
• iatrogenic infections
• infected tumors

Sponsors & Collaborators

• Clinical Center of Vojvodina: lead

Related Publications (6)

• 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: 26829352 RESULT

• 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: 31862339 RESULT

• 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: 21820786 RESULT

• 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: 18952475 RESULT

• 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: 31747058 RESULT

• 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.

  PMID: 34542654 DERIVED

MeSH Terms

Conditions

Infections; Mediastinitis; Inflammation

Condition Hierarchy (Ancestors)

Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aleksandar Kiralj, PhD

  Clinical Center of Vojvodina

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 29, 2021
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04