Corza Medical GmbH
This retrospective observational cohort study compares the effectiveness and safety of adjunctive TachoSil® fibrin sealant patch with DuraSeal® hydrogel sealant for supporting dural sealing in adult patients undergoing cranial or spinal surgery at participating United States hospitals. Medical records will be reviewed to assess clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele within 90 days after surgery. The study will use 1:1 propensity score matching to evaluate whether TachoSil® is non-inferior to DuraSeal® and will assess additional effectiveness and safety outcomes.
Inclusion Criteria: * Aged ≥ 18 years * Had an inpatient encounter to select sites with a cranial or spinal neurological surgery that involves dural sealing performed and discharged during January 1, 2017, and March 31, 2026 * Had use of TachoSil® or DuraSeal® sealants during the cranial or spinal neurological surgery as supportive dural sealing method Note: Any surgery meeting the above criteria is considered index surgery Exclusion Criteria: * Index surgery was trauma-related * Had an infection within 7 days prior to index date * Had any neurosurgery involving dural opening during the 12…
TachoSil® is an absorbable fibrin sealant patch consisting of equine collagen coated with human fibrinogen and thrombin.
DuraSeal® sealants are polyethylene glycol (PEG) based hydrogel.