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Prevention of Neurosurgical Wound Infections (POWI)

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ClinicalTrials.gov Identifier: NCT00915967
Recruitment Status : Unknown
Verified September 2012 by Kim J. Burchiel, Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2009
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Kim J. Burchiel, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infections Drug: Vancomycin Drug: Placebo (Saline Solution) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Project: Prevention of Neurosurgical Wound Infections
Study Start Date : July 2009
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

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


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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

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

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 Posted: June 8, 2009    Key Record Dates
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