Bone and Joint InfectionFibFlapINCT04373278
Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Mandibular osteitis after flap reconstruction is rare but is a serious infection with significant sequelae. The aim of this study is to describe this type of infection Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- failure of reconstruction of the mandibule by free fibula flap
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 1 Jun 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients having had infection after a free flap reconstruction of the mandibule
Who may be able to join
- patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020
Who cannot join
- non-bony flap
Trial locations and contacts
1 site in 1 country.
About this study
Mandibular osteitis after flap reconstruction is rare but is a serious infection with significant sequelae.
The aim of this study is to describe this type of infection
- Conditions
- Bone and Joint Infection
- Being tested
- failure of reconstruction of the mandibule by free fibula flap
- Keywords
- mandibular, flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
failure of reconstruction of the mandibule by free fibula flapOther
description of failure of reconstruction of the mandibule by free fibula flap:delay, type of bacteria involved in the failure, treatment, outcome
| Study group | Role | What they receive |
|---|---|---|
| description of infection of free fibula flap reconstruction | Not described Receives: Other: failure of reconstruction of the mandibule by free fibula flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of failure after free fibula flap reconstruction of the mandible
description of failure after free fibula flap reconstruction of
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]
Secondary outcomes (1)
rate of bacteria involved in failure after free fibula flap reconstruction of the mandible
epidemiology of bacteria which causes the failure
Measured: when bacteria had growth up on culture; usually 2-3 weeks after the sample extracted on the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Jun 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373278
- Sponsor's protocol ID
- 19-273
- Acronym
- FibFlapI
- Status last verified
- Sep 2023
- First submitted
- 30 Apr 2020
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04373278
- Acronym / sponsor ID
- FibFlapI / 19-273
- Conditions
- Bone and Joint Infection
- Keywords
- mandibular, flap
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 4 May 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.
Mandibular osteitis after flap reconstruction is rare but is a serious infection with significant sequelae.
The aim of this study is to describe this type of infection
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| description of infection of free fibula flap reconstruction | – | Other: failure of reconstruction of the mandibule by free fibula flap |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients having had infection after a free flap reconstruction of the mandibule
Key inclusion criteria (1 listed)
- patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020
Key exclusion criteria (1 listed)
- non-bony flap
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 |
|---|---|---|
| failure of reconstruction of the mandibule by free fibula flapdescription of failure of reconstruction of the mandibule by free fibula flap:delay, type of bacteria involved in the failure, treatment, outcome | Other | description of infection of free fibula flap reconstruction |
Primary outcome
rate of failure after free fibula flap reconstruction of the mandible
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]
description of failure after free fibula flap reconstruction of
1 secondary outcome
rate of bacteria involved in failure after free fibula flap reconstruction of the mandible
Time frame: when bacteria had growth up on culture; usually 2-3 weeks after the sample extracted on the surgery
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 22 Sep 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bone and Joint Infection, run by Hospices Civils de Lyon 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 1 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 22 Sep 2023. 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?
rate of failure after free fibula flap reconstruction of the mandible (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]). 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 22 Sep 2023.