Antibiotic Use & Open Fracture of the Lower Extremity
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Methodist Health System
- Enrollment
- 948
- Locations
- 1
- Primary Endpoint
- Aminoglycoside Usage
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
cephalosporin
cephalosporin
Intervention: Cephalosporin 1St Generation (Drug)
cephalosporin and aminoglycoside
the combination of cephalosporin and aminoglycoside.
Intervention: Cephalosporin 1St Generation (Drug)
cephalosporin and aminoglycoside
the combination of cephalosporin and aminoglycoside.
Intervention: Aminoglycosides (Drug)
Outcomes
Primary Outcomes
Aminoglycoside Usage
Time Frame: Within 24 hours of admission
The necessity of aminoglycoside usage for patients with open lower extremity fractures.
Secondary Outcomes
- comorbidities(Within 24 hours of admission)
- surgical site infection (SSI)(Within 24 hours of admission)
- Demographics(Within 24 hours of admission)
- deep space infection (DSI)(Within 24 hours of admission)
- Total hospital length of stay - HLOS(Within 24 hours of admission)
- grade of fracture(Within 24 hours of admission)