Antibiotic Use & Open Fracture of the Lower Extremity

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.

Study Overview

• Status: Withdrawn
• Conditions: Lower Extremity Fracture
• Intervention / Treatment: Drug: Cephalosporin 1St Generation; Drug: Aminoglycosides

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 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).

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cephalosporin	Drug: Cephalosporin 1St Generation
Active Comparator: cephalosporin and aminoglycoside; the combination of cephalosporin and aminoglycoside.	Drug: Cephalosporin 1St Generation; Drug: Aminoglycosides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aminoglycoside Usage	The necessity of aminoglycoside usage for patients with open lower extremity fractures.	Within 24 hours of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	age, sex, ethnicity	Within 24 hours of admission
comorbidities	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
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
deep space infection (DSI)	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
grade of fracture	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission
surgical site infection (SSI)	in regards to necessity of aminoglycoside usage for patients with open lower extremity fractures	Within 24 hours of admission

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Michael S. Truitt, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Gustilo
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Open; Anti-Bacterial Agents; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Carbohydrates; Glycosides; beta Lactam Antibiotics; First Generation Cephalosporins; Aminoglycosides
• Other Study ID Numbers: 041.TRA.2016.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes