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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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In context

Infections

2,093 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's enrollment of 289 is close to the median of 300 across 685 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Clinical Center of Vojvodina is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2014 to primary completion in Dec 2020, 83 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 14, 2021
First posted
Apr 29, 2021
StartActual
Jan 1, 2014
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Apr 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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