WithdrawnPhase 3

Antibiotic Use & Open Fracture of the Lower Extremity

Stopped: Study terminated by PI due to limited resources, no data collected

0Started 2016-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Aminoglycoside Usage

Timeframe: Within 24 hours of admission

Trial details

NCT IDNCT05267977

SponsorMethodist Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-25

View on ClinicalTrials.gov More Lower Extremity Fracture trials