Septic Management and Outcome of Open Fracture

NCT04418882 — Completed, 400 participants, Hospices Civils de Lyon

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Septic Management and Outcome of Open Fracture : a 7 Years Retrospective Cohort Study

Registry	NCT04418882
Status	Completed
Study type	Observational
Enrollment	400 (Actual)
Sponsor	Hospices Civils de Lyon (Other)
Conditions	Open Fracture, Pseudarthrosis, Bone and Joint Infection
Interventions	management and follow up of all open fractures (Other)
Dates	start 2020-05-15, primary completion 2020-07-01, completion 2021-12-01, first posted 2020-06-05, last updated 2022-01-12
Locations	1 site in France

-Summary

The aim is the study of the management and outcome of the open fractures.

Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.

The management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).

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+Arms and interventions

Arm	Type	Interventions	Description
non septic open fracture		Other: management and follow up of all open fractures	patients having had an open fracture without septic evolution
septic open fracture		Other: management and follow up of all open fractures	patients having had an open fracture with septic evolution

management and follow up of all open fractures (Other): to evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too.

+Outcome measures

Primary outcomes

description of non septic open fracture [24 months]: description of surgical management
description of patients with non septic open fracture [1 month]: description of patients : average age, medical background
description of septic open fracture : bacteriology [24 months]: type of bacteria involved in the infection
description of septic open fracture : evolution [24 months]: description of symptoms
description of septic open fracture : management [24 months]: description of surgical and medical management
description of septic open fracture : patients [24 months]: description of patients : average age, medical background
description of pseudarthrosis: symptoms [24 months]: description of symptoms
description of pseudarthrosis : management [24 months]: description of management: surgical and medical management
description of septic pseudarthrosis : patients [24 months]: description of patients : average age, medical background
description of septic pseudarthrosis : bacteriology [24 months]: type of bacteria involved in the infection
treatment failure [24 months]: rate and description of treatment failure.Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* all patients with open fractures

Exclusion Criteria:

\-

+Locations (1)

Facility	City	Country	Status
Hospices Civils de Lyon	Lyon	France