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Tobramycin Injection for Open Fractures
Study Summary
This trial is testing whether a combination of local and systemic antibiotics can reduce the rate of infection in people with open fractures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am over 18 years old.I am allergic to tobramycin or similar antibiotics.I am over 18 years old.I have an open fracture in my arm, leg, or both.I was treated with a dissolvable antibiotic carrier before.I am younger than 18 years old.I have an open fracture in my arm, leg, or both.
- Group 1: Standard of Care Treatment Group
- Group 2: Tobramycin Treatment Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are patients of a certain age being excluded from this research?
"This particular clinical trial is only recruiting patients that fall between 18 to 80 years old. In comparison, there are 286 clinical trials for people under the age of 18 and 973 for elderly people."
For what disorders is Tobramycin Injection most often prescribed?
"Tobramycin Injection can be used to fight off bacterial infections like burkholderia cepacia infection and eye infections."
How many volunteers are taking part in this experiment?
"That is correct. The clinicaltrials.gov website currently has information indicating that this trial is seeking participants. The trial was originally posted on 1/10/2022 and was last updated on 1/28/2022. The trial is looking for 300 participants across 1 site."
Could you please share what other research has been done on Tobramycin Injection?
"Currently, there are 12 clinical trials studying the effects of Tobramycin Injection. 5 of these trials are in Phase 3. Most of the trials are taking place in Aurora, Colorado, but there are also 16 other locations across the country where these trials are taking place."
Has the FDA cleared Tobramycin Injection for public use?
"There is a fair amount of data supporting tobramycin injection's efficacy and safety, so it received a score of 3."
How can I become a participant of this experiment?
"This research study is open to 300 people that have suffered fractures. The fracture must be open and the victim must be between 18-80 years old. There are additional requirements that the fracture be in the arm, leg, or both."
Are there any more people needed for this clinical test?
"This clinical trial is still recruiting patients, according to the latest information on clinicaltrials.gov. The trial was originally posted on January 10th, 2022, and was last updated on January 28th, 2022."
What makes this particular clinical trial different from others?
"Tobramycin Injection is being studied in 12 ongoing clinical trials spread out over 9 cities and 7 countries. The first trial for Tobramycin Injection was held in 2010 and, since then, 495 studies have been completed."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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