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Antibiotic Coated Nail for Preventing Infection in Broken Bones
Study Summary
This trial will compare outcomes of patients treated with a prophylactic antibiotic coated nail vs. traditional IM nailing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” 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?
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- I cannot speak English or Spanish.I am under 18 years old.I have a severe open fracture in my shin that needs surgery with a metal rod.I am 18 years old or older.
- Group 1: Intramedullary Nail
- Group 2: Antibiotic Coated Intramedullary Nail
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
At what number of sites is this trial currently taking place?
"Currently, the trial is recruiting out of nine facilities scattered across Fairfax, Temple Terrace and Winston-Salem. To reduce travel time for participants, it is advised to pick a location as close to you as possible."
Are there any vacancies for participants in this research program?
"According to the details registered on clinicaltrials.gov, this medical experiment is not currently recruiting participants. It was initially posted in December 1st 2022 and last updated October 25th 2022. However, there are 362 other trials that are open for enrollment at present time."
What potential risks accompany Antibiotic Coated Intramedullary Nail implementation?
"There is a significant amount of evidence in support of Antibiotic Coated Intramedullary Nail's safety, so it received the highest score possible (3)."
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