Factors Associated With Complications of Cervical Necrotizing Fasciitis
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|ClinicalTrials.gov Identifier: NCT02847234|
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
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.
|Condition or disease|
|Cervical Necrotizing Fasciitis|
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Factors Associated With Complications of Cervical Necrotizing Fasciitis|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847234
|Contact: Thomas Rimmelé, MD PhD||(0)4 72 11 69 88 ext +firstname.lastname@example.org|
|Contact: Myrtille Fouché, Resident||(0)6 13 78 24 54 ext +email@example.com|
|Intensive Care unit, Edouard Herriot Hospital||Recruiting|
|Lyon, France, 69003|
|Contact: Myrtille Fouché, resident (0)613782554 ext +33 firstname.lastname@example.org|
|Contact: Thomas Rimmelé, MD, PHD (0)4 72 11 69 88 ext +33 email@example.com|
|Principal Investigator:||Thomas Rimmelé, MD PhD||Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE|