Status:
WITHDRAWN
Antibiotic Use & Open Fracture of the Lower Extremity
Lead Sponsor:
Methodist Health System
Conditions:
Lower Extremity Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05267977
Start Date
August 1 2016
End Date
May 25 2022
Last Update
November 20 2024
Active Locations (1)
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1
Methodist Health System
Dallas, Texas, United States, 75203