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

  • France
      • 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
Other: failure of reconstruction of the mandibule by free fibula flap
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

Hospices Civils de Lyon

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.

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