Pharmacokinetics of Preoperative Vancomycin

Surgical Site Infection Clinical Trial

Official title: Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients

Status Completed

Clinical Trial Summary

A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.

Clinical Trial Description

Background: Vancomycin is used for antibiotic prophylaxis in pediatric surgical patients without a complete understanding of plasma and soft tissue pharmacokinetics. Guidelines recommend incision within 60 minutes after administration; however, tissue concentrations of vancomycin at that early time may not be therapeutic. The Investigators conducted a study of plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to characterize intraoperative vancomycin pharmacokinetics.

Patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over one hour. Skin biopsies were taken at incision and skin closure. Blood samples were also collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient was still in surgery. Population pharmacokinetic (PK) analysis was performed to characterize PK parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin concentrations vs. time. ;

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection
• Vancomycin

• NCT number: NCT03453684
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2012
• Completion date: July 20, 2015