Hemopatch Performance Evaluation: A Prospective Observational Registry
NCT ID: NCT03392662
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
621 participants
OBSERVATIONAL
2017-11-29
2019-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hemopatch Sealant Use with Hepatobiliary Surgery
Hemopatch
Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with General Surgery
Hemopatch
Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Lung Surgery
Hemopatch
Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Cardiovascular Surgery
Hemopatch
Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Neurological/Spinal Surgery
Hemopatch
Patients received product at the discretion of their surgeon.
Hemopatch Sealant Use with Urologic Surgery
Hemopatch
Patients received product at the discretion of their surgeon.
Interventions
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Hemopatch
Patients received product at the discretion of their surgeon.
Eligibility Criteria
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Inclusion Criteria
* Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:
1. Hepato-biliary (liver, pancreas, gallbladder)
2. General surgery (in thyroid and other regions)
3. Cardiovascular (heart and vessels)
4. thoracic (lung and mediastinum)
5. Urological (kidney, prostate, and bladder
6. Neurological (dura mater, brain and spinal cord)
* Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery
Exclusion Criteria
* Patients who had intraoperative pulsatile or severe bleeding at the target application site (TAS)
* Patients who had an active infection at the TAS
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Locations
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Innsbruck Universitaetsklinik
Innsbruck, , Austria
Fakultní nemocnice u sv. Anny v Brně
Brno, , Czechia
Krajská Nemocnice Liberec
Liberec, , Czechia
Fakultní Nemocnice Ostrava
Ostrava, , Czechia
Thomayerova Nemocnice
Prague, , Czechia
Marien-Krankenhaus Bergisch Gladbach
Bergisch Gladbach, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
ASKLEPIOS Klinik St. Georg
Hamburg, , Germany
Universitaetsklinikum Regensburg
Regensburg, , Germany
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Hospital de Vall d'Hebrón
Barcelona, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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References
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Lombardo C, Lopez-Ben S, Boggi U, Gutowski P, Hrbac T, Krska L, Marquez-Rivas J, Russello D, York E, Zacharias M. Hemopatch(R) is effective and safe to use: real-world data from a prospective European registry study. Updates Surg. 2022 Oct;74(5):1521-1531. doi: 10.1007/s13304-022-01353-y. Epub 2022 Aug 20.
Other Identifiers
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BXU011443
Identifier Type: -
Identifier Source: org_study_id
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