Title {1}	Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial
Trial registration {2a and 2b}.	Clinicaltrials.gov, NCT04086550
Protocol version {3}	Protocol version 2.0, February 2021
Funding {4}	Polyganics BV Rozenburglaan 15A 9727 DL Groningen, The Netherlands
Author details {5a}	1 Department of Neurosurgery, University of New Mexico, Albuquerque, NM, United States of America 2 Department of Neurology and Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands 3 Department of Translational Neuroscience, University Medical Center Utrecht, Brain Center, Utrecht University, Utrecht, The Netherlands 4 Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland
Name and contact information for the trial sponsor {5b}	Polyganics BV Rozenburglaan 15A 9727 DL Groningen, The Netherlands
Role of sponsor {5c}	Sponsor co-designed the study with the authors. The sponsor, who is funding the study, is involved in site selection and day-to-day performance of the trial with regards to device accountability and study training. The regulatory submissions, data monitoring and data analysis is performed by a contract research organization (CRO). Interpretation of the data is performed in accordance with the coordinating investigators. The sponsor integrates the information provided by the CRO and coordinating investigators into the study report, which is reviewed by the CRO and coordinating investigators for final approval of the report. The authors have full freedom in writing and submitting the academic report. Draft material should be provided to the sponsor for review at least 30 days prior to submission or presentation date. The sponsor may require that the Investigators delete from their documents any reference to the sponsor’s confidential information.