Evolution of Facial Trauma During COVID Containment Measures

NCT04355442 | Completed

• 1 other identifier: RECHMPL20_0228
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 global pandemic has led to a major professional and social national reorganization: professional because it involves a redeployment of medical staff and material resources, and social because it imposes prolonged containment measures on an entire population. The maxillofacial trauma activity is mainly linked to sports or leisure accidents, fights and road accidents. It seems to appear since the beginning of containment measures a significant drop in maxillofacial trauma activity at the national level, which, if it is demonstrated in a significant way in several French hospital centers, would allow to redeploy the material and human resources related to this activity on sectors in tension due to the pandemic.

Conditions

Maxillofacial Injuries; Skull Fractures; COVID-19

Keywords

Pandemics; Maxillofacial fractures; Facial trauma; Containment; Quarenteen; Outbreak

Outcome Measures

Primary Outcomes (1)

• evolution of number of maxillofacial trauma

  evolution of number of maxillofacial trauma during COVID-19 first month of containment measures compared to the same period in 2018 and 2019.the number of patients from different investigator centers operated for a facial fracture occurring between March 16, 2020 and April 15, 2020 will be compared to the number of patients in these same centers operated for a facial fracture during the same period in 2018 and in 2019. A sub-group analysis, by center, will also be carried out.

  1 year

Secondary Outcomes (2)

• variability in terms of type of trauma

  1 year

• Comparative assessment of types of trauma by the inter-regional variability

  1 year

Study Arms (2)

contained patients

contained patients

Procedure: Facial fractures reduction or osteosynthesis

Comparative patients

Comparative patients

Procedure: Facial fractures reduction or osteosynthesis

Interventions

Facial fractures reduction or osteosynthesis PROCEDURE

Facial fractures reduction or osteosynthesis

Comparative patients; contained patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with facial trauma requiring surgery

You may qualify if:

• Maxillo-facial fracture
• Requiring
• Trauma that occured between March 16 and April 15, 2020 or 2018 or 2019
• All ages

You may not qualify if:

• Patients who refused the collection of their data

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Unités de CMF des CHU de Paris (Dr Davrou - Pitié salpetrière): collaborator
• Amiens (Dr Dapke): collaborator
• Nantes (Pr Corre): collaborator
• Toulouse (Pr Lauwers - Purpan): collaborator
• Marseille (Dr Foletti - La conception): collaborator
• Nice (Dr Savoldelli): collaborator
• Clermont Ferrand (Dr Sesque): collaborator
• Perpignan (Dr Llobet): collaborator
• Lyon (Dr Bourlet - Croix Rousse): collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Maxillofacial Injuries; Skull Fractures; COVID-19

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Marie de BOUTRAY, PH

  UH MONTPELLIER

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: April 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-04

Locations

FR (1)