Open FractureNCT04418882
Septic Management and Outcome of Open Fracture
An observational study of Open Fracture and Pseudarthrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Fracture, Pseudarthrosis, Bone and Joint Infection
- What is being tested?
- management and follow up of all open fractures
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients having had an open fractures managed at the HCL
Who may be able to join
- all patients with open fractures
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Open Fracture, Pseudarthrosis, Bone and Joint Infection
- Being tested
- management and follow up of all open fractures
- Keywords
- bone and joint infection, Pseudarthrosis, Open Fracture
- Medical subject headings
- Fractures, Open, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management and follow up of all open fracturesOther
to evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too.
| Study group | Role | What they receive |
|---|---|---|
| non septic open fracture | patients having had an open fracture without septic evolution Receives: Other: management and follow up of all open fractures | |
| septic open fracture | patients having had an open fracture with septic evolution Receives: Other: management and follow up of all open fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of non septic open fracture
description of surgical management
Measured: 24 months
description of patients with non septic open fracture
description of patients : average age, medical background
Measured: 1 month
description of septic open fracture : bacteriology
type of bacteria involved in the infection
Measured: 24 months
description of septic open fracture : evolution
description of symptoms
Measured: 24 months
description of septic open fracture : management
description of surgical and medical management
Measured: 24 months
description of septic open fracture : patients
description of patients : average age, medical background
Measured: 24 months
description of pseudarthrosis: symptoms
description of symptoms
Measured: 24 months
description of pseudarthrosis : management
description of management: surgical and medical management
Measured: 24 months
description of septic pseudarthrosis : patients
description of patients : average age, medical background
Measured: 24 months
description of septic pseudarthrosis : bacteriology
type of bacteria involved in the infection
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 May 2020
- Primary completion1 Jul 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open FractureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418882
- Sponsor's protocol ID
- 20-204
- Status last verified
- Jan 2022
- First submitted
- 3 Jun 2020
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septic Management and Outcome of Open Fracture : a 7 Years Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04418882
- Acronym / sponsor ID
- 20-204
- Conditions
- Open Fracture, Pseudarthrosis, Bone and Joint Infection
- Keywords
- bone and joint infection, Pseudarthrosis, Open Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non septic open fracture | – | Other: management and follow up of all open fracturespatients having had an open fracture without septic evolution |
| septic open fracture | – | Other: management and follow up of all open fracturespatients having had an open fracture with septic evolution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having had an open fractures managed at the HCL
Key inclusion criteria (1 listed)
- all patients with open fractures
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management and follow up of all open fracturesto evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too. | Other | non septic open fracture, septic open fracture |
Primary outcome
description of non septic open fracture
Time frame: 24 months
description of surgical management
description of patients with non septic open fracture
Time frame: 1 month
description of patients : average age, medical background
description of septic open fracture : bacteriology
Time frame: 24 months
type of bacteria involved in the infection
description of septic open fracture : evolution
Time frame: 24 months
description of symptoms
description of septic open fracture : management
Time frame: 24 months
description of surgical and medical management
description of septic open fracture : patients
Time frame: 24 months
description of patients : average age, medical background
description of pseudarthrosis: symptoms
Time frame: 24 months
description of symptoms
description of pseudarthrosis : management
Time frame: 24 months
description of management: surgical and medical management
description of septic pseudarthrosis : patients
Time frame: 24 months
description of patients : average age, medical background
description of septic pseudarthrosis : bacteriology
Time frame: 24 months
type of bacteria involved in the infection
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Fracture and Pseudarthrosis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of non septic open fracture (time frame: 24 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.