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.

Autor: Coucke B; Research Group Experimental Neurosurgery and Neuroanatomy and Leuven Brain Institute, Department of Neurosciences, KU Leuven, Belgium. birgit.coucke@kuleuven.be.; Allergy and Clinical Immunology Research Group, Department of Microbiology, Immunology & Transplantation, KU Leuven, Leuven, Belgium. birgit.coucke@kuleuven.be., Van Hoylandt A; Neurosurgery, University Hospitals Leuven, Leuven, Belgium., Jorissen M; Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.; Laboratory of Experimental Otorhinolaryngology, Department of Neurosciences, KU Leuven, Leuven, Belgium., Meulemans J; Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.; Department of Oncology, Section Head and Neck Oncology, KU Leuven, Leuven, Belgium., Decramer T; Research Group Experimental Neurosurgery and Neuroanatomy and Leuven Brain Institute, Department of Neurosciences, KU Leuven, Belgium.; Neurosurgery, University Hospitals Leuven, Leuven, Belgium., van Loon J; Research Group Experimental Neurosurgery and Neuroanatomy and Leuven Brain Institute, Department of Neurosciences, KU Leuven, Belgium.; Neurosurgery, University Hospitals Leuven, Leuven, Belgium., Vander Poorten V; Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.; Department of Oncology, Section Head and Neck Oncology, KU Leuven, Leuven, Belgium., Theys T; Research Group Experimental Neurosurgery and Neuroanatomy and Leuven Brain Institute, Department of Neurosciences, KU Leuven, Belgium.; Neurosurgery, University Hospitals Leuven, Leuven, Belgium., Van Gerven L; Allergy and Clinical Immunology Research Group, Department of Microbiology, Immunology & Transplantation, KU Leuven, Leuven, Belgium.; Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven, Leuven, Belgium.; Laboratory of Experimental Otorhinolaryngology, Department of Neurosciences, KU Leuven, Leuven, Belgium.
Jazyk: angličtina
Zdroj: Trials [Trials] 2023 Jul 31; Vol. 24 (1), pp. 488. Date of Electronic Publication: 2023 Jul 31.
DOI: 10.1186/s13063-023-07492-w
Abstrakt: Background: Recent advances in endoscopic endonasal transsphenoidal approaches (EETA) for skull base lesions have resulted in a significant increase in extent and complexity of skull base defects, demanding more elaborate and novel reconstruction techniques to prevent cerebrospinal fluid (CSF) leakage and to improve healing. Currently, commercially available fibrin sealants are often used to reinforce the skull base reconstruction. However, problems have been reported regarding hypersensitivity reactions, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) membranes as an alternative for commercially available fibrin glues in EETA-related skull base reconstruction reinforcement.
Methods/design: This multicenter, prospective randomized controlled trial aims to demonstrate non-inferiority of L-PRF membranes compared to commercially available fibrin sealants in EETA cases (1) without intra-operative CSF-leak as dural or sellar floor closure reinforcement and (2) in EETA cases with intra-operative CSF-leak (or very large defects) in which a classic multilayer reconstruction has been made, as an additional sealing. The trial includes patients undergoing EETA in three different centers in Belgium. Patients are randomized in a 1:1 fashion comparing L-PRF with commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage. Secondary endpoints are identification of risk factors for reconstruction failure, assessment of rhinological symptoms, and interference with postoperative imaging. Additionally, a cost-effectiveness analysis is performed.
Discussion: With this trial, we will evaluate the safety and efficacy of L-PRF compared to commercially available fibrin sealants.
Trial Registration: ClinicalTrials.gov NCT03910374. Registered on 10 April 2019.
(© 2023. The Author(s).)
Databáze: MEDLINE
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