Prevention of Neurosurgical Wound Infections (POWI)
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|ClinicalTrials.gov Identifier: NCT00915967|
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Infections||Drug: Vancomycin Drug: Placebo (Saline Solution)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Pilot Project: Prevention of Neurosurgical Wound Infections|
|Actual Study Start Date :||May 13, 2009|
|Actual Primary Completion Date :||December 19, 2014|
|Actual Study Completion Date :||December 19, 2014|
Subjects in the experimental group will receive Vancomycin injected 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.
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.
- Incidence of Infection That Requires Removal of the Neurosurgical Device [ Time Frame: Six months post-operation ]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.
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
|United States, Oregon|
|University Hospital, Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|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|