NCT00915967|CompletedResultsDMC
Prevention of Neurosurgical Wound Infections
POWI
Pilot Project: Prevention of Neurosurgical Wound Infections
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Sponsor study identifier
interventional
214
1 country
1
Study Start
May 13, 2009
Actual (reported)Primary Completion
December 19, 2014
Actual (reported)Study Completion
December 19, 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 19, 2014
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2009
Actual (reported)June 5, 2009
Actual (reported)June 8, 2009
Actual (reported)December 19, 2014
Actual (reported)December 19, 2014
Actual (reported)April 30, 2019
Actual (reported)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
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.
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.
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.
University Hospital, Oregon Health & Science University
Portland, Oregon, 97239, United States
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.
Kim J Burchiel, MD
Department of Neurological Surgery, Oregon Health & Science University
Valerie C Anderson, PhD, MCR
Department of Neurological Surgery, Oregon Health & Science University
Stephen T Magill, PhD
School of Medicine, Oregon Health & Science University
214 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2009
First Posted
June 8, 2009
Study Start
May 13, 2009
Actual (reported)Checklist to Prevent MRSA Surgical Site Infections
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 19, 2014
Actual (reported)Study Completion
December 19, 2014
Actual (reported)Last Updated
April 30, 2019
Results First Posted
April 30, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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