Clinical trial NCT05267977: Antibiotic Use & Open Fracture of the Lower Extremity
Official title: Antibiotic Use & Open Fracture of the Lower Extremity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lower Extremity Fracture
Keywords: Gustilo
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Aminoglycoside Usage
timeFrame: Within 24 hours of admission
Secondary outcomes:
measure: Demographics
timeFrame: Within 24 hours of admission
measure: comorbidities
timeFrame: Within 24 hours of admission
measure: Total hospital length of stay - HLOS
timeFrame: Within 24 hours of admission
measure: deep space infection (DSI)
timeFrame: Within 24 hours of admission
measure: grade of fracture
timeFrame: Within 24 hours of admission
measure: surgical site infection (SSI)
timeFrame: Within 24 hours of admission
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael S. Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References: