Antibiotic Use & Open Fracture of the Lower Extremity

Methodist Health System

Status and phase: Withdrawn; Phase 3

Conditions: Lower Extremity Fracture

Treatments: Drug: Cephalosporin 1St Generation; Drug: Aminoglycosides

Study type: Interventional

Funder types: Other

Identifiers

NCT05267977

041.TRA.2016.D

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

cephalosporin

Active Comparator group

Description:

cephalosporin

Treatment:

Drug: Cephalosporin 1St Generation

cephalosporin and aminoglycoside

Active Comparator group

Description:

the combination of cephalosporin and aminoglycoside.

Treatment:

Drug: Aminoglycosides

Drug: Cephalosporin 1St Generation