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CompletedNCT04865003Updated Apr 29, 2021

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

An observational study in Infection, Mediastinitis and Neck Abscess, sponsored by Clinical Center of Vojvodina. Completed. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by Clinical Center of Vojvodina · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
289
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Infection
  • Mediastinitis
  • Neck Abscess
  • Inflammation
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
289 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othertreatment of infection
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What researchers measure

Primary outcomes

  1. Incidence of mediastinitis

    Neck and chest computed tomography (CT)

    Time frame: Within 6 hours of admission

Secondary outcomes

  1. Microbiological findings in DNI and DNM

    Prevalence of microorganisms in mediastinitis

    Time frame: Within 1 week of admission

  2. Average number of hospital days

    Comparison of average number of hospital days in DNI and DNM

    Time frame: Through study completion, an average of one month

  3. Incidence of complications

    Complications among DNI and DNI+DNM groups

    Time frame: Within 30 days from admission

  4. Number of infected deep neck spaces

    Neck and chest computed tomography (CT)

    Time frame: Within 6 hours of admission

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26829352 ↗
  • 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. PubMed 31862339 ↗
  • 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. PubMed 21820786 ↗
  • 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. PubMed 18952475 ↗
  • 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. PubMed 31747058 ↗
  • 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. PubMed 34542654 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT04865003
Lead sponsor
Clinical Center of Vojvodina
Responsible party
Denis Brajković (Principal Investigator, Clinical Center of Vojvodina) — Principal investigator
First posted
Apr 29, 2021
Start date
Jan 1, 2014
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Apr 29, 2021

Study contacts

Aleksandar Kiralj, PhD
study director · Clinical Center of Vojvodina
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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