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

• Sponsor: Clinical Center of Vojvodina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04865003
• Collaborator: (none)
• Enrollment: 289
• Actual Duration (Months): 84

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection; Mediastinitis; Neck Abscess; Inflammation	Other: treatment of infection

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 Design

• Study Type: Observational
• Actual Enrollment: 289 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Prognostic Factors for Descending Necrotizing Mediastinitis Development in Deep Space Neck Infections - A Retrospective Study
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incidence of mediastinitis [Within 6 hours of admission]

   Neck and chest computed tomography (CT)

Secondary Outcome Measures

1. Microbiological findings in DNI and DNM [Within 1 week of admission]

   Prevalence of microorganisms in mediastinitis

2. Average number of hospital days [Through study completion, an average of one month]

   Comparison of average number of hospital days in DNI and DNM

3. Incidence of complications [Within 30 days from admission]

   Complications among DNI and DNI+DNM groups

4. Number of infected deep neck spaces [Within 6 hours of admission]

   Neck and chest computed tomography (CT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Clinical Center of Vojvodina

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Denis Brajković, Principal Investigator, Clinical Center of Vojvodina
• ClinicalTrials.gov Identifier: NCT04865003
• Other Study ID Numbers: 1208983
• First Posted: Apr 29, 2021
• Last Update Posted: Apr 29, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mediastinitis; Inflammation

Study Results

No Results Posted as of Apr 29, 2021