Antibiotic Use & Open Fracture of the Lower Extremity

Lower Extremity Fracture Clinical Trial

Official title:

Antibiotic Use & Open Fracture of the Lower Extremity

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05267977
• Other study ID #: 041.TRA.2016.D
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: August 2016
• Est. completion date: August 2025

Study information

• Verified date: March 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 948
• Est. completion date: August 2025
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Lower Extremity Fracture

Intervention

Drug:
• Cephalosporin 1St Generation

• Aminoglycosides

Locations

Country	Name	City	State
United States	Methodist Health System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aminoglycoside Usage	The necessity of aminoglycoside usage for patients with open lower extremity fractures.	Within 24 hours of admission
Secondary	Demographics	age, sex, ethnicity	Within 24 hours of admission
Secondary	comorbidities	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
Secondary	Total hospital length of stay - HLOS	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
Secondary	deep space infection (DSI)	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
Secondary	grade of fracture	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
Secondary	surgical site infection (SSI)	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission