Bone Infection, Non-healing Wound, Nosocomial Infection, Pneumonia, Postoperative Complications, Pseudarthrosis, Surgical Site Infection, Wound Infection
Conditions
Keywords
long bone fracture, trauma
Brief summary
At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk.
Detailed description
Trauma patients suffer from a high risk of complications that ranges from soft tissue complications, surgical site infection till bone non-union. Comorbidities are often know to be associated with complications. Also certain blood markers could be identified to be an indicator. However, certain risk factors have only been investigated in small trauma cohorts so far. This study is a prospective multi center cohort trail that aims to collect all clinical data, comorbidities, medication, blood markers in trauma patients after long bone fractures. In a 6 months and one year follow up patients with complications will be identified. Methods of machine learning will help to identify a risk factor profile for certain groups of patients with complications. The aim of the study is to early identify patients at risk for a complication after trauma according to their blood marker, clinical, comorbidity and medication profile.
Interventions
None listed
Sponsors
BG Klinik Murnau
BG Trauma Center Ludwigshafen
BG Klinikum Duisburg
BG Klink Hamburg
Unfallkrankenhaus Berlin
BG Ambulanz Bremen
Bundeswehrkrankenhaus Ulm
Paracelsus Universität Salzburg
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Inclusion criteria
* acute long bone fracture (humerus, ulna, radius, femur, tibia) with surgical treatment
Exclusion criteria
* associated severe injury (ISS \> 16) * associated traumatic brain injury * associated traumatic spine injury * dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| any complication after long bone fracture | 6 months, one year | number of patients that suffer from a complication after surgical treatment of a primary long bone fracture |
| Clavien Dindo Classification | 6 months, one year | Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Charlson Comorbidity Index (CCI) | Initially | Charlson Comorbidity Index classifies comorbidities of patients. All particiapants will be screened for their comorbidities and classified according to CCI. |
| number of medications | initally | Intake of medication will be assessed and number of medication will be identified. |
| EuroQual 5 Dimensions Questionnaire (EQ5D5L) | initially, 6 months, one year. | EQ5D5L will be assessed from each participant to identify their quality of life. |
| patient reported outcome measure associated with the lone bone fracture | initially, 6 months, one year. | patient reported outcome measure will be assessed by each patient that is associated with the lone bone fracture |
Countries
Germany
Contacts
Primary ContactMarie K Reumann, MD
Backup ContactMika Rollmann, MD
Outcome results
None listed