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Antibiotic Use & Open Fracture of the Lower Extremity

NCT05267977 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Lower Extremity Fracture

Interventions

DRUG

Cephalosporin 1St Generation

DRUG

Aminoglycosides

Sponsors & Collaborators

  • Methodist Health System

    lead OTHER

Principal Investigators

  • Michael S. Truitt, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2022-05-25
Completion
2022-05-25
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267977 on ClinicalTrials.gov