Prevention of Neurosurgical Wound Infections (POWI)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Surgical Wound Infections

Treatments: Drug: Vancomycin; Drug: Placebo (Saline Solution)

Study type: Interventional

Funder types: Other

Identifiers

NCT00915967

IRB_5170

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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214 participants in 2 patient groups, including a placebo group

Vancomycin

Experimental group

Description:

Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.

Treatment:

Drug: Vancomycin

Saline

Placebo Comparator group

Description:

Subjects in the saline group will receive a Saline injection directly into the wound pocket.

Treatment:

Drug: Placebo (Saline Solution)