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NCT04373278 Clinical Trial

Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study

Bone and Joint Infection Clinical Trial

— FibFlapI  

Official title:
Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04373278
Other study ID # 19-273
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date June 1, 2019

Study information
Verified date September 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of failure after free fibula flap reconstruction of the mandible 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 rate of bacteria involved in failure after free fibula flap reconstruction of the mandible 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
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