Prevention of Neurosurgical Wound Infections

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Wound Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

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 (Saline solution)

Drug

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

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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Pilot Project: Prevention of Neurosurgical Wound Infections

Acronym: POWI

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Jun 8, 2009
Registry last updated: Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed