An observational study in Postoperative Complications, Surgical Site Infection and Wound Infection, sponsored by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu · Observational
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 2,300 is above the median of 239 across 135 observational studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Compared within Surgical Wound Infection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Postoperative Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
patients that suffer from an acute lone bone fracture, require surgical treatment and belong to the age group of being able to working (18 - 67 years old)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
any complication after long bone fracture
number of patients that suffer from a complication after surgical treatment of a primary long bone fracture
Time frame: 6 months, one year
Clavien Dindo Classification
Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year.
Time frame: 6 months, one year
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index classifies comorbidities of patients. All particiapants will be screened for their comorbidities and classified according to CCI.
Time frame: Initially
number of medications
Intake of medication will be assessed and number of medication will be identified.
Time frame: initally
EuroQual 5 Dimensions Questionnaire (EQ5D5L)
EQ5D5L will be assessed from each participant to identify their quality of life.
Time frame: initially, 6 months, one year.
patient reported outcome measure associated with the lone bone fracture
patient reported outcome measure will be assessed by each patient that is associated with the lone bone fracture
Time frame: initially, 6 months, one year.
Plan to share: No — Data of all patients will be pseudonymised. No individual participant data will be identified.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu