Septic Management and Outcome of Open Fracture

Completed

• Conditions: Open Fracture; Bone and Joint Infection; Pseudarthrosis
• Interventions: Other: management and follow up of all open fractures

• Registration Number: NCT04418882
• Lead Sponsor: Hospices Civils de Lyon

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Primary Completion: 2020-07-01
• Study Completion: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• all patients with open fractures

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non septic open fracture	management and follow up of all open fractures	patients having had an open fracture without septic evolution
septic open fracture	management and follow up of all open fractures	patients having had an open fracture with septic evolution

Primary Outcome Measures

Name	Time	Method
description of septic open fracture : evolution	24 months	description of symptoms
description of non septic open fracture	24 months	description of surgical management
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
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 : management	24 months	description of surgical and medical management
description of pseudarthrosis : management	24 months	description of management: surgical and medical management
description of septic pseudarthrosis : bacteriology	24 months	type of bacteria involved in the infection
description of pseudarthrosis: symptoms	24 months	description of symptoms
description of septic open fracture : patients	24 months	description of patients : average age, medical background
description of septic pseudarthrosis : patients	24 months	description of patients : average age, medical background

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France