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Prevention of Neurosurgical Wound Infections

NCT00915967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2019-04-30

Study results available
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Summary

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.

Conditions

  • Surgical Wound Infections

Interventions

DRUG

Vancomycin

Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.

DRUG

Placebo (Saline Solution)

Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Kim J Burchiel, MD · Department of Neurological Surgery, Oregon Health & Science University

  • Valerie C Anderson, PhD, MCR · Department of Neurological Surgery, Oregon Health & Science University

  • Stephen T Magill, PhD · School of Medicine, Oregon Health & Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-13
Primary Completion
2014-12-19
Completion
2014-12-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915967 on ClinicalTrials.gov