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Prevention of Neurosurgical Wound Infections (POWI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Kim J. Burchiel, Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00915967
First Posted: June 8, 2009
Last Update Posted: September 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kim J. Burchiel, Oregon Health and Science University
  Purpose
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.

Condition Intervention
Surgical Wound Infections Drug: Vancomycin Drug: Placebo (Saline Solution)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Project: Prevention of Neurosurgical Wound Infections

Resource links provided by NLM:


Further study details as provided by Kim J. Burchiel, Oregon Health and Science University:

Primary Outcome Measures:
  • Incidence of infection that requires removal of the neurosurgical device [ Time Frame: Six months post-operation ]

Secondary Outcome Measures:
  • The incidence of additional antibiotic usage beyond the standard of care [ Time Frame: Six months post-operation ]

Estimated Enrollment: 250
Study Start Date: July 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915967


Locations
United States, Oregon
University Hospital, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Kim J. Burchiel, Kim J. Burchiel, MD / John Raaf Professor and Chairman, Department of Neurological Surgery, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00915967     History of Changes
Other Study ID Numbers: IRB_5170
First Submitted: June 5, 2009
First Posted: June 8, 2009
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Kim J. Burchiel, Oregon Health and Science University:
Infection
Vancomycin
Neurosurgery
Stimulator
Pump
Deep Brain Stimulation
Intrathecal Pump

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents