Clinical trial NCT04865003: Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections
Official title: Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections - A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Mediastinitis
Neck Abscess
Inflammation
Lead sponsor: Clinical Center of Vojvodina
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 289
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of mediastinitis
timeFrame: Within 6 hours of admission
Secondary outcomes:
measure: Microbiological findings in DNI and DNM
timeFrame: Within 1 week of admission
measure: Average number of hospital days
timeFrame: Through study completion, an average of one month
measure: Incidence of complications
timeFrame: Within 30 days from admission
measure: Number of infected deep neck spaces
timeFrame: Within 6 hours of admission
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Center of Vojvodina
name: Aleksandar Kiralj, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.