Prevention of Neurosurgical Wound Infections (POWI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kim J. Burchiel, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00915967
First received: June 5, 2009
Last updated: September 3, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Project: Prevention of Neurosurgical Wound Infections

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Incidence of infection that requires removal of the neurosurgical device [ Time Frame: Six months post-operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of additional antibiotic usage beyond the standard of care [ Time Frame: Six months post-operation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 5, 2009
Last Updated: September 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Infection
Vancomycin
Neurosurgery
Stimulator
Pump
Deep Brain Stimulation
Intrathecal Pump

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Pharmaceutical Solutions
Vancomycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 20, 2014