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Prevention of Neurosurgical Wound Infections (POWI)

Primary Purpose

Surgical Wound Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Placebo (Saline Solution)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound Infections focused on measuring Infection, Vancomycin, Neurosurgery, Stimulator, Pump, Deep Brain Stimulation, Intrathecal Pump

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vancomycin

Saline

Arm Description

Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.

Subjects in the saline group will receive a Saline injection directly into the wound pocket.

Outcomes

Primary Outcome Measures

Incidence of Infection That Requires Removal of the Neurosurgical Device
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2009
Last Updated
April 8, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00915967
Brief Title
Prevention of Neurosurgical Wound Infections
Acronym
POWI
Official Title
Pilot Project: Prevention of Neurosurgical Wound Infections
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 13, 2009 (Actual)
Primary Completion Date
December 19, 2014 (Actual)
Study Completion Date
December 19, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infections
Keywords
Infection, Vancomycin, Neurosurgery, Stimulator, Pump, Deep Brain Stimulation, Intrathecal Pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Subjects in the saline group will receive a Saline injection directly into the wound pocket.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (Saline Solution)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Infection That Requires Removal of the Neurosurgical Device
Description
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.
Time Frame
Six months post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim J Burchiel, MD
Organizational Affiliation
Department of Neurological Surgery, Oregon Health & Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valerie C Anderson, PhD, MCR
Organizational Affiliation
Department of Neurological Surgery, Oregon Health & Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen T Magill, PhD
Organizational Affiliation
School of Medicine, Oregon Health & Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19263587
Citation
Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. doi: 10.3171/2008.6.17605.
Results Reference
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Prevention of Neurosurgical Wound Infections

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