Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients

November 3, 2026 updated by: Corza Medical GmbH

Effectiveness and Safety of TachoSil® Fibrin Sealant Patch in Comparison to a Hydrogel Sealant for Supporting Dural Sealing Among Adult Inpatients in the United States: A Retrospective, Non-Inferiority, Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Daniel Lubelski, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Raymond F. Sekula, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • Recruiting
        • University of Cincinnati College of Medicine
        • Principal Investigator:
          • Norberto Andaluz, MD, MBA, MHA, FACS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • James S. Harrop, MD, MSHQS, FACS
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Alleghany Health Network
        • Principal Investigator:
          • Alexander Yu, MD
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Health Services
        • Principal Investigator:
          • Zachary N. Litvack, MD MBA FAANS FACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients who were admitted to one of the target hospitals for a neurological surgery and discharged from January 1, 2017, to March 31, 2026 (index period) and had use of TachoSil® or DuraSeal® sealants during the neurological surgery (index surgery) as dural sealant and met the study selection criteria will be included in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TachoSil®

Adult inpatients who underwent neurological surgery with the use of TachoSil® for dural sealing support and were discharged from US hospitals from 01 January 2017 through 31 March 2026
Drug: TachoSil®

TachoSil® is an absorbable fibrin sealant patch consisting of equine collagen coated with human fibrinogen and thrombin.
DuraSeal®

Adult inpatients who underwent neurological surgery with the use of DuraSeal® for dural sealing support and were discharged from US hospitals from 01 January 2017 through 31 March 2026
Device: DuraSeal®

DuraSeal® sealants are polyethylene glycol (PEG) based hydrogel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele
Time Frame: Within 90 days post surgery

A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice verified by a glucose concentration test or β-2 transferrin test.

A clinically evident pseudomeningocele is defined as a subcutaneous visible and/or palpable fluid accumulation adjacent to or at the site of surgical incision suspected to be CSF.

If there is not a collection of CSF/pseudomeningocele, or active leak that can be sampled for β-2 transferrin test, but the participant had symptoms consistent with intracranial hypotension and/or an ex vacuo type subdural hematoma, the participant will be considered as having clinically evident CSF leak or pseudomeningocele.
Within 90 days post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint
Time Frame: Within 90 days post surgery

Non-clinically evident pseudomeningocele is defined as CSF accumulation detected only by computed tomography (CT) or magnetic resonance imaging (MRI) scan.
Within 90 days post surgery
Number of Participants Experiencing Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: Within 90 days post surgery

AEs refer to any undesirable event that is documented in a site's Electronic Medical Records (EMR) for an eligible participant as occurring within 90 days of the index surgery regardless of whether or not the events were considered causally related to TachoSil® or DuraSeal® use.

SAEs refer to any AE documented in a site's EMR for an eligible patient that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity or a congenital anomaly/birth defect.

Individual prespecified AEs and the composite categories of any expected AE and any unexpected AE will be summarized by treatment cohort.
Within 90 days post surgery
Risk of Clinically Evident CSF Leak
Time Frame: Within 90 days post surgery

A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice verified by a glucose concentration test or β-2 transferrin test.
Within 90 days post surgery
Risk of Clinically Evident Pseudomeningocele
Time Frame: Within 90 days post surgery

A clinically evident pseudomeningocele is defined as a subcutaneous visible and/or palpable fluid accumulation adjacent to or at the site of surgical incision suspected to be CSF.
Within 90 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corza Medical GmbH

Collaborators

Comprehensive Information and Analytics Services (CIAS)
Premier, Inc. Applied Sciences

Investigators

  • Principal Investigator: Ning Rosenthal, MD, PhD, MPH,, Premier Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

November 16, 2026

Study Completion (Estimated)

November 16, 2026

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL125351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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