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Intraosseous Antibiotics for Osseointegration
Sponsor: Wake Forest University Health Sciences
Summary
The purpose of this research study is to learn about the characteristics of infection in osseointegration patients. This research study will also study how safe and effective it is to use antibiotics inside the bone.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09
Completion Date
2031-12
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
intraosseous antibiotic delivery
After debridement, patients will receive intraosseous (IO) vancomycin 500mg in 150ml of normal saline during surgery. The solution will be prepared by the hospital pharmacy and administered via an IO cannula. The cannula will be placed proximal to the intramedullary fixture. In cases where a tourniquet can be utilized proximal to the IO cannula, the antibiotic is delivered as a bolus. Tourniquet must be up for 1 hour after installation of the IO cases where the residual limb is too short to allow tourniquet (pneumatic or elastic) proximal to the IO cannula, the intraosseous antibiotic must be infused at a rate not to exceed 10mg/min or less. This can be accomplished by connecting intravenous tubing to the antibiotic mixture and the IO cannula. In cases without a tourniquet, IO infusion should begin during the irrigation phase and continue through the complete closure of the wound, since it requires a significant amount of time 50-60 min.
Locations (5)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Hospital for Special Surgery
New York, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
UT Health San Antonio
San Antonio, Texas, United States