NCT00915967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2014

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

April 30, 2019

Completed
Last Updated

April 30, 2019

Status Verified

January 1, 2019

Enrollment Period

5.6 years

First QC Date

June 5, 2009

Results QC Date

January 17, 2019

Last Update Submit

April 8, 2019

Conditions

Surgical Wound Infections

Keywords

InfectionVancomycinNeurosurgeryStimulatorPumpDeep Brain StimulationIntrathecal Pump

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six months post-operation

Study Arms (2)

Vancomycin

EXPERIMENTAL

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

Drug: Vancomycin

Saline

PLACEBO COMPARATOR

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

Drug: Placebo (Saline Solution)

Interventions

VancomycinDRUG

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.

Vancomycin
Placebo (Saline Solution)DRUG

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.

Saline

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 19263587BACKGROUND

MeSH Terms

Conditions

Surgical Wound InfectionInfections

Interventions

VancomycinSaline Solution

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Director of Clinical Trials
Organization
Oregon Health & Science University
nsgclinicalresearch@ohsu.edu
503-494-4314

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kim J. Burchiel, MD / John Raaf Professor and Chairman, Department of Neurological Surgery

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 8, 2009

Study Start

May 13, 2009

Primary Completion

December 19, 2014

Study Completion

December 19, 2014

Last Updated

April 30, 2019

Results First Posted

April 30, 2019

Record last verified: 2019-01

Locations

US(1)