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New treatment option for Osteomyelitis Tibia
Official title Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
ClinicalTrials.gov ID: NCT05421741
What this study is testing
What is Antibiotic coated intramedullary Nail?
Antibiotic coated intramedullary Nail is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for osteomyelitis tibia.
Also referred to as Local Gentamicin 560 Powder, Vancomycin 2gm Liquid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients 18 years or older
- Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
You likely can't join if
- Less than 18 years of age
- Allergy to vancomycin or gentamicin
- Unable to speak English or Spanish
- Pregnant and lactating women
- Prisoner
- Unable to follow up for 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Temple Terrace, Florida, United States
- Macon, Georgia, United States
- Lexington, Kentucky, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Concord, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Hershey, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Roanoke, Virginia, United States
- Winchester, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Temple Terrace, Florida, United States; Macon, Georgia, United States; Lexington, Kentucky, United States; Chapel Hill, North Carolina, United States; Charlotte, North Carolina, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.