WithdrawnPhase 3

Antibiotic Use & Open Fracture of the Lower Extremity

Stopped: Study terminated by PI due to limited resources, no data collected

0Started 2016-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Aminoglycoside Usage

Timeframe: Within 24 hours of admission

Trial details

NCT IDNCT05267977

SponsorMethodist Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-25

View on ClinicalTrials.gov More Lower Extremity Fracture trials