Maxillofacial InjuriesTraumaxNCT04355442
Evolution of Facial Trauma During COVID Containment Measures
An observational study of Maxillofacial Injuries and Skull Fractures, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillofacial Injuries, Skull Fractures, COVID-19
- What is being tested?
- Facial fractures reduction or osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with facial trauma requiring surgery
Who may be able to join
- Maxillo-facial fracture
- Requiring
- Trauma that occured between March 16 and April 15, 2020 or 2018 or 2019
- All ages
Who cannot join
- Patients who refused the collection of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Maxillofacial Injuries, Skull Fractures, COVID-19
- Being tested
- Facial fractures reduction or osteosynthesis
- Keywords
- Pandemics, Maxillofacial fractures, Facial trauma, Containment, Quarenteen, Outbreak
- Medical subject headings
- Maxillofacial Injuries, Skull Fractures, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial fractures reduction or osteosynthesisProcedure or surgery
Facial fractures reduction or osteosynthesis
| Study group | Role | What they receive |
|---|---|---|
| contained patients | contained patients Receives: Procedure: Facial fractures reduction or osteosynthesis | |
| Comparative patients | Comparative patients Receives: Procedure: Facial fractures reduction or osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
variability in terms of type of trauma
study of variability in terms of type of trauma with and without confinement.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Apr 2020
- Primary completion1 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- Marie de BOUTRAY, PH, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355442
- Sponsor's protocol ID
- RECHMPL20_0228
- Acronym
- Traumax
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Maxillofacial Trauma Activity During COVID-19 Containment Measures: a French Multicentric Comparative Observational Study
- ClinicalTrials.gov ID
- NCT04355442
- Acronym / sponsor ID
- Traumax / RECHMPL20_0228
- Conditions
- Maxillofacial Injuries, Skull Fractures, COVID-19
- Keywords
- Pandemics, Maxillofacial fractures, Facial trauma, Containment, Quarenteen, Outbreak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- 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)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contained patients | – | Procedure: Facial fractures reduction or osteosynthesiscontained patients |
| Comparative patients | – | Procedure: Facial fractures reduction or osteosynthesisComparative patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with facial trauma requiring surgery
Key inclusion criteria (4 listed)
- Maxillo-facial fracture
- Requiring
- Trauma that occured between March 16 and April 15, 2020 or 2018 or 2019
- All ages
Key exclusion criteria (1 listed)
- Patients who refused the collection of their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial fractures reduction or osteosynthesisFacial fractures reduction or osteosynthesis | Procedure or surgery | Comparative patients, contained patients |
Primary outcome
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.
2 secondary outcomes
variability in terms of type of trauma
Time frame: 1 year
Comparative assessment of types of trauma by the inter-regional variability
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie de BOUTRAY, PH study director
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Injuries and Skull Fractures, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of number of maxillofacial trauma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.