OsteitisBoFOCNCT05367713
Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management
An observational study of Osteitis and Cranial Flap, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteitis, Cranial Flap
- What is being tested?
- patients having had an osteitis of the cranial flap after craniectomy
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 1 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cranial flap osteitis after craniectomy, treated at CRIOAc Lyon.
Who may be able to join
- Patients with cranial flap osteitis after craniectomy
- Patients who did not object to participating in the study
- Adult patients
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA, 04 26 73 29 38, eugenie.mabrut@chu-lyon.fr
About this study
Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.
- Conditions
- Osteitis, Cranial Flap
- Being tested
- patients having had an osteitis of the cranial flap after craniectomy
- Keywords
- Osteitis, cranial flap
- Medical subject headings
- Osteitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients having had an osteitis of the cranial flap after craniectomyOther
description of management and failure of cranial flap after craniectomy
| Study group | Role | What they receive |
|---|---|---|
| patients having had an osteitis of the cranial flap after craniectomy | Not described Receives: Other: patients having had an osteitis of the cranial flap after craniectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of cranial flap osteitis after craniectomy
proportion of patients
Measured: between 2010 and 2021
Secondary outcomes (1)
rate of failure in management of cranial flap osteitis after craniectomy
proportion of patients having a failure
Measured: between 2010 and 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Apr 2022
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteitisStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367713
- Sponsor's protocol ID
- 682
- Acronym
- BoFOC
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management
- ClinicalTrials.gov ID
- NCT05367713
- Acronym / sponsor ID
- BoFOC / 682
- Conditions
- Osteitis, Cranial Flap
- Keywords
- Osteitis, cranial flap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 May 2022 (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.
Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having had an osteitis of the cranial flap after craniectomy | – | Other: patients having had an osteitis of the cranial flap after craniectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cranial flap osteitis after craniectomy, treated at CRIOAc Lyon.
Key inclusion criteria (3 listed)
- Patients with cranial flap osteitis after craniectomy
- Patients who did not object to participating in the study
- Adult patients
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| patients having had an osteitis of the cranial flap after craniectomydescription of management and failure of cranial flap after craniectomy | Other | patients having had an osteitis of the cranial flap after craniectomy |
Primary outcome
rate of cranial flap osteitis after craniectomy
Time frame: between 2010 and 2021
proportion of patients
1 secondary outcome
rate of failure in management of cranial flap osteitis after craniectomy
Time frame: between 2010 and 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- website of CRIOAc LyonLink 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.
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 Osteitis and Cranial Flap, 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 3 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tristan Ferry, Md,PhD (04 26 73 29 38, tristan.ferry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of cranial flap osteitis after craniectomy (time frame: between 2010 and 2021). 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 10 May 2022.