Cervical Necrotizing Fasciitis Clinical Trial
Official title:
Factors Associated With Complications of Cervical Necrotizing Fasciitis
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.
| Status | Recruiting |
| Enrollment | 350 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| France | Intensive Care unit, Edouard Herriot Hospital | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | incidence of mediastinitis | Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding. | At the entry in ICU (Day 1) | No |
| Secondary | factors associated with mediastinitis | Computed tomography (CT) is performed at admission. Mediastinitis is described on CT finding. | At the entry in ICU (Day 1) | No |