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Status unknownNCT02847234Updated Jul 28, 2016

Factors Associated With Complications of Cervical Necrotizing Fasciitis

An observational study in Cervical Necrotizing Fasciitis, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-28.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cervical Necrotizing Fasciitis

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Keywords

  • Cervical necrotizing fasciitis
  • mediastinitis
03

In context

Mediastinitis

21 studies on the registry are indexed under Mediastinitis; 3 are open to participants now.

Browse Mediastinitis studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient admitted in ICU for management of cervical necrotizing fasciitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
350 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. incidence of mediastinitis

    Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.

    Time frame: At the entry in ICU (Day 1)

Secondary outcomes

  1. factors associated with mediastinitis

    Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding.

    Time frame: At the entry in ICU (Day 1)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2016
First posted
Jul 28, 2016
Start
Jan 2015
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Jul 28, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02847234
Responsible party
Sponsor
First posted
Jul 28, 2016
Start date
Jan 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 28, 2016

Study contacts

Thomas Rimmelé, MD PhD
Contact
thomas.rimmele@chu-lyon.fr
(0)4 72 11 69 88 ext. +33
Myrtille Fouché, Resident
Contact
myrtille_fouche@hotmail.com
(0)6 13 78 24 54 ext. +33
Thomas Rimmelé, MD PhD
principal investigator · Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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