This trial is active, not recruiting.

Condition surgical wound infections
Treatments vancomycin, placebo (saline solution)
Sponsor Oregon Health and Science University
Start date July 2009
End date January 2013
Trial size 250 participants
Trial identifier NCT00915967, IRB_5170


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
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)
Subjects in the saline group will receive a Saline injection directly into the wound pocket.
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.

Primary Outcomes

Incidence of infection that requires removal of the neurosurgical device
time frame: Six months post-operation

Secondary Outcomes

The incidence of additional antibiotic usage beyond the standard of care
time frame: Six months post-operation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Project: Prevention of Neurosurgical Wound Infections
Principal investigator Kim J Burchiel, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.