Prevention of Neurosurgical Wound Infections

Surgical Wound Infections Clinical Trial

— POWI  

Official title:

Pilot Project: Prevention of Neurosurgical Wound Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915967
• Other study ID #: IRB_5170
• Status: Completed
• Phase: N/A
• Start date: May 13, 2009
• Est. completion date: December 19, 2014

Study information

• Verified date: January 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: December 19, 2014
• Est. primary completion date: December 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound
• Surgical Wound Infection
• Surgical Wound Infections
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• Vancomycin
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)
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.

Locations

Country	Name	City	State
United States	University Hospital, Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Infection That Requires Removal of the Neurosurgical Device	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.	Six months post-operation