Septic Management and Outcome of Open Fracture

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

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).

Study Overview

• Status: Completed
• Conditions: Bone and Joint Infection; Pseudarthrosis; Open Fracture
• Intervention / Treatment: Other: management and follow up of all open fractures

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients having had an open fractures managed at the HCL

Description

Inclusion Criteria:

• all patients with open fractures

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non septic open fracture; patients having had an open fracture without septic evolution	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.
septic open fracture; patients having had an open fracture with septic evolution	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of non septic open fracture	description of surgical management	24 months
description of patients with non septic open fracture	description of patients : average age, medical background	1 month
description of septic open fracture : bacteriology	type of bacteria involved in the infection	24 months
description of septic open fracture : evolution	description of symptoms	24 months
description of septic open fracture : management	description of surgical and medical management	24 months
description of septic open fracture : patients	description of patients : average age, medical background	24 months
description of pseudarthrosis: symptoms	description of symptoms	24 months
description of pseudarthrosis : management	description of management: surgical and medical management	24 months
description of septic pseudarthrosis : patients	description of patients : average age, medical background	24 months
description of septic pseudarthrosis : bacteriology	type of bacteria involved in the infection	24 months
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: bone and joint infection; Open Fracture; Pseudarthrosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Ununited; Fractures, Bone; Fractures, Open; Pseudarthrosis
• Other Study ID Numbers: 20-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No