This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
Study Type
OBSERVATIONAL
Enrollment
924
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
Devices or drugs used to seal the dura (other than DuraSeal)
Post-operative CSF leaks
Time frame: 90 days post-operative
Post-operative surgical site infections
Deep surgical site infections as defined by the Center for Disease Control criteria.
Time frame: 90 days post-operative
Post-operative neurological serious adverse events
Time frame: 90 days post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Stanford, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
...and 26 more locations