Antibiotic Use & Open Fracture of the Lower Extremity

• Status: Suspended
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Methodist Health System
• Treatments: Cephalosporins

Criteria

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