Septic Management and Outcome of Open Fracture

January 11, 2022 updated by: Hospices Civils de Lyon

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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