Evolution of Facial Trauma During COVID Containment Measures (Traumax)

Evolution of Maxillofacial Trauma Activity During COVID-19 Containment Measures: a French Multicentric Comparative Observational Study

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Maxillofacial Injuries; Skull Fractures
• Intervention / Treatment: Procedure: Facial fractures reduction or osteosynthesis

Detailed Description

This study will compare maxillo-facial activity during the first month of COVID-19 containment measures in France with a comparable period in 2018 and 2019. This comparison will be made in 10 major French hospital centers.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with facial trauma requiring surgery

Description

Inclusion criteria:

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

Exclusion criteria:

• Patients who refused the collection of their data

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
contained patients	Procedure: Facial fractures reduction or osteosynthesis; Facial fractures reduction or osteosynthesis
Comparative patients	Procedure: Facial fractures reduction or osteosynthesis; Facial fractures reduction or osteosynthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
variability in terms of type of trauma	study of variability in terms of type of trauma with and without confinement.	1 year
Comparative assessment of types of trauma by the inter-regional variability	Comparative assessment of types of trauma by the inter-regional variability : study of the inter-regional variability of maxillofacial trauma	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Unités de CMF des CHU de Paris (Dr Davrou - Pitié salpetrière); Amiens (Dr Dapke); Nantes (Pr Corre); Toulouse (Pr Lauwers - Purpan); Marseille (Dr Foletti - La conception); Nice (Dr Savoldelli); Clermont Ferrand (Dr Sesque); Perpignan (Dr Llobet); Lyon (Dr Bourlet - Croix Rousse)
• Investigators: Study Director: Marie de BOUTRAY, PH, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Outbreak; Containment; Pandemics; Maxillofacial fractures; Facial trauma; Quarenteen
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; COVID-19; Maxillofacial Injuries; Skull Fractures
• Other Study ID Numbers: RECHMPL20_0228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No