drugset / Trial / NCT03506347

Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement

NCT03506347

Phase 2/3 Completed 24 enrolled Mayo Clinic
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at obtaining adequate tissue levels of the antibiotic than the current standard dose which is given intravenously (IV) through a wrist vein. The use of intraosseous regional administration (IORA) of vancomycin requires the use of a tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery with tourniquet use minimised or without a tourniquet at all. The aim of this study is to evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet use minimised.

Timeline

Start
2018-09-24
Primary completion
2019-01-17
Completion
2019-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 15 mg/kg Intravenous
Subject Vancomycin Other / unclassified 500 mg Intravenous

Indications