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Completed Phase 3 Interventional Results available

Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery

ClinicalTrials.gov ID: NCT02891070

Public ClinicalTrials.gov record NCT02891070. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 9:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated FS VH S/D 500 S-apr (Tisseel) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.

Brief summary

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

The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.

Study identification

NCT ID
NCT02891070
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxter Healthcare Corporation
Industry
Enrollment
224 participants

Conditions and interventions

Interventions

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
Oct 10, 2016
Primary completion
Aug 21, 2018
Completion
Aug 21, 2018
Last update posted
Sep 9, 2019

2016 – 2018

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
Southern Illinois University School of Medicine Springfield Illinois 62702
Baystate Medical Center Springfield Massachusetts 01199
Henry Ford Hospital Detroit Michigan 48202
University of Minnesota Minneapolis Minnesota 55455
University Hospitals Case Medical Center Cleveland Ohio 44106
The Ohio State University Columbus Ohio 43201
Temple University School of Medicine Philadelphia Pennsylvania 19140
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213
Houston Methodist Neurological Institute Houston Texas 77030
University of Virginia School of Medicine Charlottesville Virginia 22903

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02891070, 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 Sep 9, 2019 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02891070 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →