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

ClinicalTrials.gov ID: NCT07927413

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT07927413
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Corza Medical GmbH; Industry
Enrollment: 600 participants

Conditions and interventions

Conditions

Interventions

TachoSil® Drug
DuraSeal® Device

Drug · Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 13, 2026 (Actual)
Primary completion: Nov 16, 2026 (Estimated)
Completion: Nov 16, 2026 (Estimated)
Last update posted: Nov 10, 2026

2026

United States locations

U.S. sites: 6
U.S. states: 5
U.S. cities: 6

Facility	City	State	ZIP	Site status
Johns Hopkins University	Baltimore	Maryland	21287	Recruiting
Columbia University	New York	New York	10032	Recruiting
University of Cincinnati College of Medicine	Cincinnati	Ohio	45221	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	Recruiting
Alleghany Health Network	Pittsburgh	Pennsylvania	15212	Recruiting
Swedish Health Services	Seattle	Washington	98122	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07927413, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 12, 2026