Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study (FibFlapI)
September 21, 2023 updated by: Eugénie MABRUT, Hospices Civils de Lyon
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
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
- 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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients having had infection after a free flap reconstruction of the mandibule
Description
Inclusion Criteria:
- patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020
Exclusion Criteria:
- non-bony flap
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 |
|---|---|
|
description of infection of free fibula flap reconstruction
|
description of failure of reconstruction of the mandibule by free fibula flap:delay, type of bacteria involved in the failure, treatment, outcome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
epidemiology of bacteria which causes the failure
|
when bacteria had growth up on culture; usually 2-3 weeks after the sample extracted on the surgery
|
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)
June 1, 2019
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
April 30, 2020
First Submitted That Met QC Criteria
April 30, 2020
First Posted (Actual)
May 4, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-273
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.