Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management (BoFOC)
May 5, 2022 updated by: Hospices Civils de Lyon
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69004
- Recruiting
- Hospices Civils de Lyon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with cranial flap osteitis after craniectomy, treated at CRIOAc Lyon.
Description
Inclusion Criteria:
- Patients with cranial flap osteitis after craniectomy
- Patients who did not object to participating in the study
- Adult patients
Exclusion Criteria:
- NA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients having had an osteitis of the cranial flap after craniectomy
|
description of management and failure of cranial flap after craniectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of cranial flap osteitis after craniectomy
Time Frame: between 2010 and 2021
|
proportion of patients
|
between 2010 and 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of failure in management of cranial flap osteitis after craniectomy
Time Frame: between 2010 and 2021
|
proportion of patients having a failure
|
between 2010 and 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
May 5, 2022
First Submitted That Met QC Criteria
May 5, 2022
First Posted (Actual)
May 10, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.