Recruiting

TachoSil vs. DuraSeal

Sponsor:

Corza Medical GmbH

Code:

NCT07927413

Conditions

Cerebrospinal Fluid (CSF) Leak

Psuedomeningocele

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TachoSil®

DuraSeal®

Study Details

Brief summary:

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.

Conditions

Cerebrospinal Fluid (CSF) Leak

Psuedomeningocele

Study ID

NCT07927413

Start date

Feb 13, 2026

Status verified date

Nov, 2026

Completion date

Nov 16, 2026

Anticipated

Primary completion date

Nov 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Interventions

TachoSil®

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

DuraSeal®

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

Primary outcome measure

  • Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele [ Time Frame: Within 90 days post surgery ]

Central Contacts and Locations

Central contacts

Jeff Wilson

416-578-9058Jeff.Wilson@corza.com

Michele Young

1 689-316-8809Michele.young@corza.com

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Daniel Lubelski, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Raymond F. Sekula, MD

University of Cincinnati College of Medicine

Recruiting

Cincinnati, Ohio, United States, 45221

Principal Investigator:

Norberto Andaluz, MD, MBA, MHA, FACS

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

James S. Harrop, MD, MSHQS, FACS

Alleghany Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Alexander Yu, MD

Swedish Health Services

Recruiting

Seattle, Washington, United States, 98122

Principal Investigator:

Zachary N. Litvack, MD MBA FAANS FACS

More Information

Sponsor

Corza Medical GmbH

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • TachoSil®
  • DuraSeal® sealant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Corza Medical GmbH on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.