NCT04373278

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

Same day

First QC Date

April 30, 2020

Last Update Submit

September 21, 2023

Conditions

Bone and Joint Infection

Keywords

mandibularflap

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • rate of bacteria involved in failure after free fibula flap reconstruction of the mandible

    when bacteria had growth up on culture; usually 2-3 weeks after the sample extracted on the surgery

Study Arms (1)

description of infection of free fibula flap reconstruction

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

Interventions

failure of reconstruction of the mandibule by free fibula flapOTHER

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

description of infection of free fibula flap reconstruction

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had infection after a free flap reconstruction of the mandibule

You may qualify if:

  • patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020

You may not qualify if:

  • non-bony flap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical research asssistant

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

June 1, 2019

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

FR(1)