Evolution of Facial Trauma During COVID Containment Measures

COVID-19 Clinical Trial

— Traumax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355442
• Other study ID #: RECHMPL20_0228
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 30, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Maxillofacial Injuries
• Skull Fractures

Intervention

Procedure:
• Facial fractures reduction or osteosynthesis
Facial fractures reduction or osteosynthesis

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (10)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	variability in terms of type of trauma	study of variability in terms of type of trauma with and without confinement.	1 year
Secondary	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