Septic Management and Outcome of Open Fracture

Bone and Joint Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418882
• Other study ID #: 20-204
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients with open fractures Exclusion Criteria: -

Related Conditions & MeSH terms

• Bone and Joint Infection
• Fractures, Bone
• Fractures, Open
• Open Fracture
• Pseudarthrosis

Intervention

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

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	description of non septic open fracture	description of surgical management	24 months
Primary	description of patients with non septic open fracture	description of patients : average age, medical background	1 month
Primary	description of septic open fracture : bacteriology	type of bacteria involved in the infection	24 months
Primary	description of septic open fracture : evolution	description of symptoms	24 months
Primary	description of septic open fracture : management	description of surgical and medical management	24 months
Primary	description of septic open fracture : patients	description of patients : average age, medical background	24 months
Primary	description of pseudarthrosis: symptoms	description of symptoms	24 months
Primary	description of pseudarthrosis : management	description of management: surgical and medical management	24 months
Primary	description of septic pseudarthrosis : patients	description of patients : average age, medical background	24 months
Primary	description of septic pseudarthrosis : bacteriology	type of bacteria involved in the infection	24 months
Primary	treatment failure	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	24 months

External Links

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