Factors Associated With Complications of Cervical Necrotizing Fasciitis

July 25, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient admitted in ICU for management of cervical necrotizing fasciitis

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of mediastinitis
Time Frame: At the entry in ICU (Day 1)
Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.
At the entry in ICU (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors associated with mediastinitis
Time Frame: At the entry in ICU (Day 1)
Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.
At the entry in ICU (Day 1)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Thomas Rimmelé, MD PhD, Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE

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

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (ESTIMATE)

July 28, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0500

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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