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Trial record 2 of 17 for:    Necrotizing Fascitis

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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Cervical Necrotizing Fasciitis

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient admitted in ICU for management of cervical necrotizing fasciitis
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Thomas Rimmelé, MD PhD (0)4 72 11 69 88 ext +33 thomas.rimmele@chu-lyon.fr
Contact: Myrtille Fouché, Resident (0)6 13 78 24 54 ext +33 myrtille_fouche@hotmail.com

Locations
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France
Intensive Care unit, Edouard Herriot Hospital Recruiting
Lyon, France, 69003
Contact: Myrtille Fouché, resident    (0)613782554 ext +33    myrtille_fouche@hotmail.com   
Contact: Thomas Rimmelé, MD, PHD    (0)4 72 11 69 88 ext +33    thomas.rimmele@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Thomas Rimmelé, MD PhD Intensive Care unit, Edouard Herriot Hospital, 69003 Lyon, FRANCE

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02847234     History of Changes
Other Study ID Numbers: 69HCL16_0500
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
Cervical necrotizing fasciitis
mediastinitis
Additional relevant MeSH terms:
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Fasciitis, Necrotizing
Fasciitis
Musculoskeletal Diseases
Skin Diseases, Bacterial
Bacterial Infections