N/A
N=198
Prevention of Neurosurgical Wound Infections
Surgical Wound Infections
Bottom Line
View on ClinicalTrials.gov: NCT00915967 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Incidence of Infection That Requires Removal of the Neurosurgical Device — 97; 98 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vancomycin (Drug); Placebo (Saline Solution) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Infection That Requires Removal of the Neurosurgical Device |
97; 98 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00915967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.