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CompletedNCT04418882Updated Jan 12, 2022

Septic Management and Outcome of Open Fracture

An observational study in Open Fracture, Pseudarthrosis and Bone and Joint Infection, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-12.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Open Fracture
  • Pseudarthrosis
  • Bone and Joint Infection

Keywords

  • bone and joint infection
  • Pseudarthrosis
  • Open Fracture
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients having had an open fractures managed at the HCL

Inclusion criteria

  • all patients with open fractures

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • non septic open fracture

    patients having had an open fracture without septic evolution

    Other: management and follow up of all open fractures

  • septic open fracture

    patients having had an open fracture with septic evolution

    Other: management and follow up of all open fractures

Interventions

  • Othermanagement 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.

05

What researchers measure

Primary outcomes

  1. description of non septic open fracture

    description of surgical management

    Time frame: 24 months

  2. description of patients with non septic open fracture

    description of patients : average age, medical background

    Time frame: 1 month

  3. description of septic open fracture : bacteriology

    type of bacteria involved in the infection

    Time frame: 24 months

  4. description of septic open fracture : evolution

    description of symptoms

    Time frame: 24 months

  5. description of septic open fracture : management

    description of surgical and medical management

    Time frame: 24 months

  6. description of septic open fracture : patients

    description of patients : average age, medical background

    Time frame: 24 months

  7. description of pseudarthrosis: symptoms

    description of symptoms

    Time frame: 24 months

  8. description of pseudarthrosis : management

    description of management: surgical and medical management

    Time frame: 24 months

  9. description of septic pseudarthrosis : patients

    description of patients : average age, medical background

    Time frame: 24 months

  10. description of septic pseudarthrosis : bacteriology

    type of bacteria involved in the infection

    Time frame: 24 months

  11. 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

    Time frame: 24 months

06

Study locations

1 site
  • Hospices Civils de Lyon
    Lyon, 69004, France
07

References and documents

Related links

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT04418882
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
May 15, 2020
Primary completion
Jul 1, 2020
Completion
Dec 1, 2021
Last update
Jan 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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