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NOT YET RECRUITING
NCT07621094
NA

Intraosseous Antibiotics for Osseointegration

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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