Traumax: Evolution of Facial Trauma During COVID Containment Measures

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04355442
Collaborator
Unités de CMF des CHU de Paris (Dr Davrou - Pitié salpetrière) (Other), Amiens (Dr Dapke) (Other), Nantes (Pr Corre) (Other), Toulouse (Pr Lauwers - Purpan) (Other), Marseille (Dr Foletti - La conception) (Other), Nice (Dr Savoldelli) (Other), Clermont Ferrand (Dr Sesque) (Other), Perpignan (Dr Llobet) (Other), Lyon (Dr Bourlet - Croix Rousse) (Other)
300
1
1.9
154.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evolution of Maxillofacial Trauma Activity During COVID-19 Containment Measures: a French Multicentric Comparative Observational Study
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 30, 2020

Arms and Interventions

Arm Intervention/Treatment
contained patients

contained patients

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

Comparative patients

Comparative patients

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

Outcome Measures

Primary Outcome Measures

  1. evolution of number of maxillofacial trauma [1 year]

    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.

Secondary Outcome Measures

  1. variability in terms of type of trauma [1 year]

    study of variability in terms of type of trauma with and without confinement.

  2. Comparative assessment of types of trauma by the inter-regional variability [1 year]

    Comparative assessment of types of trauma by the inter-regional variability : study of the inter-regional variability of maxillofacial trauma

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uh Montpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04355442
Other Study ID Numbers:
  • RECHMPL20_0228
First Posted:
Apr 21, 2020
Last Update Posted:
Jul 29, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2020