Prevention of Neurosurgical Wound Infections (POWI)
|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.|
|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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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 incidence of additional antibiotic usage beyond the standard of care [ Time Frame: Six months post-operation ]
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|