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Evolution of Facial Trauma During COVID Containment Measures (Traumax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355442
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : July 29, 2020
Sponsor:
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)
Information provided by (Responsible Party):
University Hospital, Montpellier

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
Maxillofacial Injuries Skull Fractures COVID-19 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.

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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 : April 1, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. evolution of number of maxillofacial trauma [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]
    Comparative assessment of types of trauma by the inter-regional variability : study of the inter-regional variability of maxillofacial trauma



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with facial trauma requiring surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355442


Locations
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France
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
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Study Director: Marie de BOUTRAY, PH UH MONTPELLIER
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04355442    
Other Study ID Numbers: RECHMPL20_0228
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Pandemics
Maxillofacial fractures
Facial trauma
Containment
Quarenteen
Outbreak
Additional relevant MeSH terms:
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Maxillofacial Injuries
Skull Fractures
Fractures, Bone
Wounds and Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases