Intraosseous Antibiotics for Osseointegration
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.
Description
The goal of this multi-center prospective trial is to assess the characteristics of infection among patients with osseointegrated prosthesis and the safety and effectiveness of intraosseous antibiotic delivery. Participants will enroll in an observational arm. Participants who require surgery for infection may enroll in an interventional arm assessing the safety and feasibility of intraosseous antibiotic administration as a potential treatment for infection.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Treated with osseointegration for transfemoral, transhumeral, or transtibial amputation and presenting with concern for surgical site infection * \>18 years of age Exclusion Criteria: * Unable to follow up at site for 1 year * Patients that speak neither English nor Spanish * \<18 years of age
Interventions
- Procedureintraosseous 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 CampusAurora, Colorado
- Hospital for Special SurgeryNew York, New York
- Atrium Health Carolinas Medical CenterCharlotte, North Carolina
- University of Pennsylvania Perelman School of MedicinePhiladelphia, Pennsylvania
- UT Health San AntonioSan Antonio, Texas