Prevention of Neurosurgical Wound Infections

Not Applicable

Completed

• Conditions: Surgical Wound Infections
• Interventions: Drug: Vancomycin; Drug: Placebo (Saline Solution)

• Registration Number: NCT00915967
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-13
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2014-12-19
• Study Completion: 2014-12-19
• Status Verified: 2019-01
• Results First Submitted: 2019-01-17
• Results First Submitted QC: 2019-04-08
• Last Update Submitted: 2019-04-08
• Results First Posted: 2019-04-30
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket.
Saline	Placebo (Saline Solution)	Subjects in the saline group will receive a Saline injection directly into the wound pocket.

Primary Outcome Measures

Name	Time	Method
Incidence of Infection That Requires Removal of the Neurosurgical Device	Six months post-operation	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.

Trial Locations

Locations (1)

University Hospital, Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States