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Topical Vancomycin in Neurosurgery

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Christopher Kellner

on 13 June 2014

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Transcript of Topical Vancomycin in Neurosurgery

Surgical Site Infections
Lister J. On a new method of treating compound fracture, abscess,
etc., with observations on the conditions of suppuration. Lancet
1867; 1:326-329.

History
Recent Studies
Topical Vancomycin in Cardiac Surgery
A MultiCenter,
Multidisciplinary Study
Funding Agency: Agency for HealthCare Research and Quality

Timeline
Start Date: August 1st, 2014
Completion date: July 30th, 2019

Targeted Enrollment: 2700 patients over 4 years, 9 months.
Power analysis based on a 75% reduction in SSI in the literature.
Accounting for a 50% participation rate.
Accomodating 3% loss for interim analyses

Total Funding: $2.5 million dollars over 5 years.


Inclusion
18 years and older
Neurosurgical Procedure for any reason at NYPH

Exclusion
No dural or dural-substitute closure
Impaired renal function (Baseline Cr>1.5)
Vancomycin allergy
Evidence of infection at or adjacent to operative site
Undergoing spinal instrumentation


Inclusion and Exclusion
Criteria
Surgical Site Infection within 30 days of surgery
Identified by telephone interview within 48 hours of the 30 day endpoint.
Primary Endpoint
Dimitri Sigounas
Resident Research Day
June 13th, 2014

Vancomycin Powder Prophylaxis in Craniotomy
The Procedure
Application of the study drug
If post-operative labs and/or morning labs on POD1 are drawn, a serum vancomycin level will be sent.

If the patient has CSF accessed post-operatively, a vancomycin level will be sent.

If the patient has a wound drain, a vancomycin level will be sent on POD 1 and 2.
Outcome Assessment
Skin Flora Assessment
Prospective, active accounting of SSI in neurosurgery at NYP.

Evaluate the effect of topical vancomycin in neurosurgical procedures.

Determine if and how topical vancomycin is distributed in the serum, CSF, and wound drain output.

Determine if and how topical application of vancomycin alters skin flora
Rational for the Trial
Basic Trial Details
The Trial Protocol
Implications
Trial Origins
Martone WJ, Nichols RL. Recognition, prevention, surveillance, and management of surgical site infections: introduction to the problem and symposium overview. CLIN INFECT DIS. 2001 Sep 1;33 Suppl 2:S67–8.


SSIs occur in up to 500,000 patients per year in the US
LOS is extended an average of 9.7 days per SSI
Cost is increased by $20,842 per admission
Total national annual cost is $1.6 billion


Surgical Site Infections

O'Keeffe AB, Lawrence T, Bojanic S. Oxford craniotomy infections database: A cost analysis of craniotomy infection. Br J Neurosurg. 2012 Apr;26(2):265–9.

Lassen B, Helseth E, Rønning P, Scheie D, Johannesen TB, Mæhlen J, et al. Surgical mortality at 30 days and complications leading to recraniotomy in 2630 consecutive craniotomies for intracranial tumors. Neurosurgery. 2011 May;68(5):1259–68–discussion1268–9.

30-day outcome
Minor disability in 12.8%
Major disability in 7.7%
Death in 5.1%
Cost
$2100 per-patient and $4.5 billion nationally in 1995
$14,166 in a British post-craniotomy study in 2012

Surgical Site Infections in Cranial Neurosurgery

McClelland S III. Postoperative intracranial neurosurgery infection rates in North America versus Europe: A systematic analysis. American Journal of Infection Control. 2008 Oct;36(8):570–3.

Korinek A-M, Golmard J-L, Elcheick A, Bismuth R, van Effenterre R, Coriat P, et al. Risk factors for neurosurgical site infections after craniotomy: a critical reappraisal of antibiotic prophylaxis on 4578 patients. Br J Neurosurg. 2005 Jan;19(2):155–62.

SSI in NSG increases LOS 10.9 days
Cost increase is estimated at $25,897
117,000 craniotomies in 2010 per NIS
2.4% infection rate and 1.37% MRSA-associated rate
Extrapolating nationally:
585,000 craniotomies nationally
14,040 post-operative infections


Surgical Site Infections in Cranial Neurosurgery

Alexander JW: The contributions of infection control to a century of surgical progress. Ann Surg. 201:423 1985 3883923
Vander Salm TJ, Okike ON, Pasque MK, Pezzella AT, Lew R, Traina V, et al. Reduction of sternal infection by application of topical vancomycin. J. Thorac. Cardiovasc. Surg. 1989 Oct;98(4):618–22.
Topical Vancomycin in Spine Surgery
NYP Infection Data
Dr. Sander Connolly
Co-Investigators:
Dr. Peter Angevine
Dr. Frank Lowy
Dr. Emilia Bagiella
Resident Coordinators:
Christopher Kellner
Brett Youngerman
Dr. Jared Knopman
Resident Coordinator:
Dimitri Sigounas
Basic Details
Secondary Endpoints
Vancomycin levels in serum, CSF, and drain output.

Incidence of the development of vancomycin resistence identified on skin swab
Potential inpatients are identified by the neurosurgery service and this is communicated to the clinical coordinator; outpatients are identified by providers.

Consent is performed in the preoperative area or clinic by the clinical coordinator after inclusion and exclusion criteria are evaluated.

Randomization is performed at the time of consent and a study number is attached to the patient's chart.

In the OR, the circulating nurse obtains the corresponding vial of study drug from the pharmacy.


A skin swab will be taken in the area of the planned incision at the time of consent.

A skin swab will be taken in the area of the incision or wound dressing on discharge or no later than POD4

A skin swab will be taken during follow-up or mailed in by the patient from the area of the incision within 14 days of POD90.
If post-operative labs and morning labs on POD1 are drawn, a serum vancomycin level will be sent.

If The patient has CSF accessed post-operatively, a vancomycin level will be sent.

If the patient has a wound drain, a vancomycin level will be sent on POD 1 and 2.
Outcome Assessment
XX/YY/ZZ

Post-operatively, the patient began following commands on POD3, and was extubated on POD4. On POD7, she was noted to have clear drainage from the wound and mental status changes. An EVD was placed and CSF sent with a profile consistent with bacterial meningitis. The patient was started on broad spectrum antibiotics, CSF drained for wound protection, and the wound oversewn . Despite EVD drainage, the wound began leaking again on POD11. A CT demonstrated a collection and the patient was brought back to the OR for a wound washout.

A 37 year old female with no PMH presents with dizziness and severe headache. She was brought to the ED by a family member where she collapsed in the waiting room. CT demonstrated a 30cc left cerebellar hemorrhage with brainstem compression. She was brought emergently to the OR for suboccipital decompression and clot evacuation.

XX/YY/ZZ

Safety
A drug safety monitoring board consisting of a neurologist, neurosurgeon, biostatistician, and neurointensivist unrelated to the study will meet quarterly to review patient data.

A BMP will be sent on all patients on POD1 to monitor for acute renal failure.

The clinical coordinator will monitor the medical record for severe adverse events including subjective hearing loss and acute renal failure. If these events are noted by the clinical team, the coordinator will be contacted and the DSMB will be contact within 24 hours.

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