Prevention of Neurosurgical Wound Infections

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Project: Prevention of Neurosurgical Wound Infections

Conditions
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Surgical Wound Infections

Intervention / Treatment
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* Drug: Vancomycin
* Drug: Placebo (Saline Solution)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vancomycin<br>Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. | Drug: Vancomycin<br>* 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.<br>|
| Placebo Comparator: Saline<br>Subjects in the saline group will receive a Saline injection directly into the wound pocket. | Drug: Placebo (Saline Solution)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stimulator, Infection, Vancomycin, Neurosurgery, Pump, Deep Brain Stimulation, Intrathecal Pump