Clinical Trial: Factors Associated With Complications of Cervical Necrotizing Fasciitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Factors Associated With Complications of Cervical Necrotizing Fasciitis
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.
Detailed Summary:
Sponsor: Hospices Civils de Lyon
Current Primary Outcome: incidence of mediastinitis [ Time Frame: At the entry in ICU (Day 1) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: factors associated with mediastinitis [ Time Frame: At the entry in ICU (Day 1) ]
Original Secondary Outcome: Same as current
Information By: Hospices Civils de Lyon
Dates:
Date Received: July 25, 2016
Date Started: January 2015
Date Completion: December 2016
Last Updated: July 25, 2016
Last Verified: July 2016