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OpenTrials
Completed

NCT Number: NCT04373278

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

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

Completed

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Key information

Conditions

Bone and Joint Infection

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

failure of reconstruction of the mandibule by free fibula flap

Other

description of failure of reconstruction of the mandibule by free fibula flap:delay, type of bacteria involved in the failure, treatment, outcome

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FibFlapI

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 4, 2020
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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