Antibiotic Use & Open Fracture of the Lower Extremity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2022-05-25

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Lower Extremity Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase: Part 1: Retrospective multi-center study. Part 2: Prospective multi-center study. Number of Sites: Methodist Health System and the associated center. Description of Intervention: Phase 1: No intervention. Phase 2: Patients will be randomized to receive either cephalosporin or the combination of cephalosporin and aminoglycoside.

Study Duration: Phase 1: 3 years. Phase 2: 5 years. Subject Participation Duration: Phase 2: Patients will be enrolled in the study until discharge from the hospital. Study participation is strictly voluntary and patient can withdraw at any time.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cephalosporin

Group Type ACTIVE_COMPARATOR

Cephalosporin 1St Generation

Intervention Type DRUG

cephalosporin and aminoglycoside

the combination of cephalosporin and aminoglycoside.

Group Type ACTIVE_COMPARATOR

Cephalosporin 1St Generation

Intervention Type DRUG

Aminoglycosides

Intervention Type DRUG

Interventions

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Cephalosporin 1St Generation

Intervention Type DRUG

Aminoglycosides

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No