Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
NCT ID: NCT03910374
Last Updated: 2021-10-05
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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UNKNOWN
NA
220 participants
INTERVENTIONAL
2018-11-01
2023-12-31
Brief Summary
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Detailed Description
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Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
Dural closure
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
Dural closure
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
Interventions
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Dural closure
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 and \< 70 years
* Written informed consent
* Willingness to adhere to visit schedules
Exclusion Criteria
* Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results
* Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study
* Enrollment in other investigational drug trial(s)
18 Years
70 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Laura Van Gerven
Clinical professor, Doctor
Principal Investigators
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Laura Van Gerven, prof
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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AZ Sint-Jan
Bruges, , Belgium
UZ Leuven
Leuven, , Belgium
Fundació Clínic Per A La Recerca Biomèdica
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Coucke B, Van Hoylandt A, Jorissen M, Meulemans J, Decramer T, van Loon J, Vander Poorten V, Theys T, Van Gerven L. Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial. Trials. 2023 Jul 31;24(1):488. doi: 10.1186/s13063-023-07492-w.
Other Identifiers
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s61636
Identifier Type: -
Identifier Source: org_study_id
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