Antibiotic Use & Open Fracture of the Lower Extremity

Study Overview
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Brief Summary
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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
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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).

Official Title
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Antibiotic Use & Open Fracture of the Lower Extremity

Conditions
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Lower Extremity Fracture

Intervention / Treatment
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* Drug: Cephalosporin 1St Generation
* Drug: Aminoglycosides


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cephalosporin<br>cephalosporin | Drug: Cephalosporin 1St Generation<br> <br> |
| Active Comparator: cephalosporin and aminoglycoside<br>the combination of cephalosporin and aminoglycoside. | Drug: Cephalosporin 1St Generation<br> <br> Drug: Aminoglycosides<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aminoglycoside Usage | The necessity of aminoglycoside usage for patients with open lower extremity fractures. | Within 24 hours of admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | age, sex, ethnicity | Within 24 hours of admission | 
| comorbidities | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures | Within 24 hours of admission | 
| Total hospital length of stay - HLOS | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures | Within 24 hours of admission | 
| deep space infection (DSI) | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures | Within 24 hours of admission | 
| grade of fracture | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures | Within 24 hours of admission | 
| surgical site infection (SSI) | in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures | Within 24 hours of admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gustilo