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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
214
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, United States
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.
Time frame: Six months post-operation
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