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

April 27, 2021 updated by: Denis Brajković, Clinical Center of Vojvodina

Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections - A Retrospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of mediastinitis
Time Frame: Within 6 hours of admission
Neck and chest computed tomography (CT)
Within 6 hours of admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Center of Vojvodina

Investigators

  • Study Director: Aleksandar Kiralj, PhD, Clinical Center of Vojvodina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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