The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
228
Adjunctive bioresorbable patch
synthetic absorbable sealants
Stanford University
Palo Alto, California, United States
Baptist Health
Jacksonville, Florida, United States
Mayo Clinic
Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection
Time frame: 30 days
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Jacksonville, Florida, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
University of New Mexico
Albuquerque, New Mexico, United States
Lenox Hill Hospital
New York, New York, United States
University of Cincinnatti
Cincinnati, Ohio, United States
OHSU
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University Hospitals of Innsbruck
Innsbruck, Austria
...and 7 more locations