Northwell Health Enrolling Spinal Fusion Patients in Study to Reduce Postoperative Staphylococcus aureus Infections

Mark B. Eisenberg, MD, Northwell's lead investigator of the study.

MANHASSET, NY -- Doctors at Northwell Health’s Neuroscience Institute have begun enrolling patients in an international research study to test the safety and efficacy of an investigational vaccine to prevent Staphylococcus aureus (S.aureus) infections following spinal surgery.

S. aureus is a leading cause of hospital-acquired infections in the United States. Hospital-acquired S. aureus, as well as methicillin-resistant S. aureus (MRSA) infections are often associated with a longer hospital stay, greater morbidity and

mortality and high treatment costs. The study will test the safety and efficacy of Pfizer’s S. aureus 4-antigen vaccine (SA4Ag) in adult patients undergoing elective posterior lumbar spinal fusion surgery.

           
“We are continuously looking for ways to reduce surgical site and bloodstream infections,” said Mark B. Eisenberg, MD, Northwell’s lead investigator of the study. “The vaccine, which is administered 10-60 days prior to spinal surgery is being tested to see if it causes the body’s immune system to make

antibodies which can recognize and kill staph infections that enter the body through the cut in the skin made during surgery.”

 

Participant Eligibility

Locally, the research study is being conducted at Northwell Health’s Neuroscience Institute in Manhasset, NY. The center is looking to enroll about 50 patients at this site. Participants must be 18-85 years of age and about to receive

elective posterior instrumented lumbar spinal fusion surgery.

 

About the Study

The study is a Phase 2b randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of the SA4Ag vaccine and determine if it can help

prevent infections caused by staph in patients undergoing spinal fusion surgery. Patients will be closely monitored for six months after their surgery. Antibody levels in bloodstream will be measured one time before vaccination and at three

study visits afterwards. In addition, a simple swabbing of the nose and throat will be done before vaccination and at each study visit afterwards to measure staph bacteria levels in these two common areas where the bacteria can be found. Study

participants will be reimbursed for up to $275 to cover their out-of-pocket travel expenses.

For more information about the study or to see if you are eligible, call 516-562-2483 or go click here.

 

About Northwell Health
Northwell Health (formerly North Shore-LIJ Health System) is New York State’s largest health care provider and private employer. With 21 hospitals and nearly 450 outpatient practices, we serve more than 1.8 million people annually in the metro New York area and beyond. Our 61,000 employees work to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institute. We're training the next generation of medical professionals at the visionary Hofstra Northwell School of Medicine and the School of Graduate Nursing and Physician Assistant Studies. And we offer health insurance through CareConnect. For information on our services in more than 100 medical specialties, visit Northwell.edu.

About Northwell Health’s Neuroscience Institute

The Neuroscience Institute, part of Northwell Health, consists of multidisciplinary clinical and research teams that provide patients with state-of-the-art treatments for the entire spectrum of neurological and neurosurgical disorders, including brain aneurysms,

AVM’s, stroke, traumatic brain injury, movement disorders, brain and spinal cord tumors, diseases of the spine, muscle and peripheral nerves, Chiari malformation, syringomyelia, neurodegenerative diseases, pain, epilepsy and neurological diseases of

infancy and childhood. To learn more about the Neuroscience Institute, click here.

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