Prophylactic Antibiotic Coated Nail to Prevent Infection
This study is comparing two ways to prevent infection after severe leg fractures (open tibia fractures). You might be eligible if you are 18 or older and need surgery for a Gustilo Type II or III open tibia fracture. The study is testing an antibiotic-coated intramedullary nail (a rod placed inside the bone) containing vancomycin and gentamicin, against a standard intramedullary nail. The main goal is to see how many participants develop a deep surgical site infection (SSI) within 12 months. This research aims to find better ways to reduce infections, which are a major problem for people with these types of injuries. The study plans to enroll 484 participants, but its current status is unclear.
- Study design
- This is a randomized clinical trial, meaning participants will be randomly assigned to receive either the antibiotic-coated nail or the standard nail. The study plans to enroll 484 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for deep surgical site infection for up to 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
At a glance
Conditions
Where it's being run
15 sites across 9 statesStudy leadership
- Joseph Hsu, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Number of Participants who develop deep surgical site infection (SSI)Day 30 through month 12
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.