Factors Associated With Complications of Cervical Necrotizing Fasciitis

• Conditions: Cervical Necrotizing Fasciitis

• Registration Number: NCT02847234
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.

The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.

Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Study First Posted: 2016-07-28
• Last Update Posted: 2016-07-28
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Patient admitted in ICU for management of cervical necrotizing fasciitis between 2005 and 2016.

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Exclusion Criteria

• Patients admitted in ICU for management of cervical abscess without cervical necrotizing fasciitis
• Age < 18 years

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of mediastinitis	At the entry in ICU (Day 1)	Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.

Secondary Outcome Measures

Name	Time	Method
factors associated with mediastinitis	At the entry in ICU (Day 1)	Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.

Trial Locations

Locations (1)

Intensive Care unit, Edouard Herriot Hospital; 🇫🇷 Lyon, France