Prevention of Neurosurgical Wound Infections (POWI)

April 8, 2019 updated by: Kim J. Burchiel, Oregon Health and Science University

Pilot Project: Prevention of Neurosurgical Wound Infections

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • University Hospital, Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • deep brain stimulators (DBS)
  • spinal cord stimulators (SCS)
  • motor cortex stimulators (MCS)
  • vagus nerve stimulators (VNS)
  • peripheral nerve stimulators (PNS)

Exclusion Criteria:

  • allergies to vancomycin
  • immunocompromise or taking immunosuppressant drugs
  • currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin
  • diagnosed renal failure
  • currently undergoing chemotherapy
  • pregnancy
  • non-english speakers
  • unable to return for follow-up, or unable to be contacted by telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vancomycin
Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.
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.
Placebo Comparator: Saline
Subjects in the saline group will receive a Saline injection directly into the wound pocket.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Infection That Requires Removal of the Neurosurgical Device
Time Frame: Six months post-operation
The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.
Six months post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Kim J Burchiel, MD, Department of Neurological Surgery, Oregon Health & Science University
  • Principal Investigator: Valerie C Anderson, PhD, MCR, Department of Neurological Surgery, Oregon Health & Science University
  • Principal Investigator: Stephen T Magill, PhD, School of Medicine, Oregon Health & Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2009

Primary Completion (Actual)

December 19, 2014

Study Completion (Actual)

December 19, 2014

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_5170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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