TachoSil vs DuraSeal for Supporting Dural Sealing in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes medical records from adults who had cranial or spinal surgery with dural sealing, comparing outcomes between TachoSil and DuraSeal sealants. It uses 1:1 propensity score matching to see if TachoSil is non-inferior to DuraSeal and to evaluate safety and effectiveness through 90-day post-surgery events. Primary outcomes include clinically evident CSF leak or pseudomeningocele within 90 days, with additional safety considerations being monitored. Data are drawn from multiple US institutions and led by Corza Medical GmbH, with CIAS, Premier, Inc. Applied Sciences as collaborators.

Why it matters

Who can join: the full rules

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-month look-back period
* Had neoplasm of dura mater/meningioma, requiring resection of dura during index visit (the earliest visit meeting selection criteria) or 12-month look-back period
* Was pregnant at index visit
* Had a CSF leak during the 12-month look-back period
* If the surgical approach was transbasal or transpetrosal, if the arachnoid membrane and CSF- containing system remained intact, or if there was \>1 dura opening (excluding extra ventricular or lumbar drains) during index surgery
* Had use of Evarrest patch, Tisseel, Adherus, CraniSeal, Duragen, fibrin glue or other dural sealing products during index surgery
* Had radiation therapy to surgical field in the 3 months prior to index date
* Had chronic corticosteroid use in the 3 months prior to index date
* Had both TachoSil® and DuraSeal® used for dural closure during index neurological surgery

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• University of Cincinnati College of Medicine
  Cincinnati, Ohio, United States Recruiting
• Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting
• Alleghany Health Network
  Pittsburgh, Pennsylvania, United States Recruiting
• Swedish Health Services
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Ning Rosenthal, MD, PhD, MPH, — Premier Inc
• Study coordinator: Jeff Wilson
• Email: Jeff.Wilson@corza.com
• Phone: 416-578-9058

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.