Lower Extremity Fracture
Conditions
Keywords
Gustilo
Brief summary
It is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. The primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. Hypothesis: adding aminoglycoside on top of cephalosporin in treating lower extremity fracture will make no significant difference in term of clinical outcomes when compared to cephalosporin alone.
Detailed description
The trauma patient is particularly susceptible to renal injury due to factors such as renal hypoperfusion in the acute setting, the concomitant administration of necessary intravenous contrast agents for diagnostic, and sometimes additionally therapeutic imaging (3). This is additionally complicated by the presentation of trauma patients with pre-existing renal disease. This study will assess whether prophylactic antibiotics \<72hrs have similar outcomes as ≥ 72 hrs of antibiotics, whether type of antibiotics impacts outcomes in patients in either group, help determine the incidence of infection in Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin) or dual agent (cephalosporin + aminoglycoside) and the complication profile of patients with Gustilo Type III lower extremity fracture when treated either with a single agent (cephalosporin 1st generation) or dual agent (cephalosporin 1st generation + aminoglycoside).
Interventions
DRUGCephalosporin 1St Generation
DRUGAminoglycosides
Sponsors
Methodist Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase: Part 1: Retrospective multi-center study. Part 2: Prospective multi-center study. Number of Sites: Methodist Health System and the associated center. Description of Intervention: Phase 1: No intervention. Phase 2: Patients will be randomized to receive either cephalosporin or the combination of cephalosporin and aminoglycoside. Study Duration: Phase 1: 3 years. Phase 2: 5 years. Subject Participation Duration: Phase 2: Patients will be enrolled in the study until discharge from the hospital. Study participation is strictly voluntary and patient can withdraw at any time.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients ≥ 18 years of age * All patients with open grade II or grade III lower extremity open fractures according to the Gustilo Classification of open fracture.
Exclusion criteria
* Any significant injuries in addition to the lower extremity fracture as determined by the PI that may confound the data. * Inability to give informed consent or comply with data acquisition (Part 3). * Pregnant or breast feeding patients due to the potential risks to the mother and/or fetus. * Prisoners * Previous bone malignancy * Bowel or enteric injury at index admission * TBI of AIS ≥ 5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aminoglycoside Usage | Within 24 hours of admission | The necessity of aminoglycoside usage for patients with open lower extremity fractures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | Within 24 hours of admission | age, sex, ethnicity |
| comorbidities | Within 24 hours of admission | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures |
| Total hospital length of stay - HLOS | Within 24 hours of admission | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures |
| deep space infection (DSI) | Within 24 hours of admission | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures |
| grade of fracture | Within 24 hours of admission | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures |
| surgical site infection (SSI) | Within 24 hours of admission | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures |
Contacts
PRINCIPAL_INVESTIGATORMichael S. Truitt, MD
The Methodist Hospital Research Institute
Outcome results
None listed