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OpenTrials
Completed

NCT Number: NCT04418882

Septic Management and Outcome of Open Fracture

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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Key information

Conditions

Open Fracture Bone and Joint Infection Fractures, Bone Fractures, Open Fractures, Ununited Pseudarthrosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients with open fractures

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

  1. description of non septic open fracture

    Time frame: 24 months

    description of surgical management

  2. description of patients with non septic open fracture

    Time frame: 1 month

    description of patients : average age, medical background

  3. description of septic open fracture : bacteriology

    Time frame: 24 months

    type of bacteria involved in the infection

  4. description of septic open fracture : evolution

    Time frame: 24 months

    description of symptoms

  5. description of septic open fracture : management

    Time frame: 24 months

    description of surgical and medical management

  6. description of septic open fracture : patients

    Time frame: 24 months

    description of patients : average age, medical background

  7. description of pseudarthrosis: symptoms

    Time frame: 24 months

    description of symptoms

  8. description of pseudarthrosis : management

    Time frame: 24 months

    description of management: surgical and medical management

  9. description of septic pseudarthrosis : patients

    Time frame: 24 months

    description of patients : average age, medical background

  10. description of septic pseudarthrosis : bacteriology

    Time frame: 24 months

    type of bacteria involved in the infection

  11. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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