At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.
In Brief
A clinical study evaluating Implantation of the ArtiFascia® and Implantation of other commercial suturable dural substitute for Dural Tear and Cerebrospinal Fluid Leak. Completed, enrolled 92 participants across 9 sites in 5 countries.
Detailed Summary
The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery. Subjects with planned cranial neurosurgery participated in this study. During the surgery the dura is likely to be cut and damaged. A damaged dura can cause a leakage of brain fluids (cerebrospinal fluid \[CSF\] leakage) and increase the risk of infections. The damaged dura can be fixed with dural patch like ArtiFascia®. ArtiFascia® is a bioabsorbable medical synthetic dural replacement that aids in the regeneration of a new dura. Furthermore, it incorporates a sealing layer capable of minimizing CSF leakage and infection.
Study Details
Timeline
Interventions
Following are the general instructions for use for the ArtiFascia®: * Cut the ArtiFascia® to the required shape under aseptic conditions * Apply ArtiFascia® to the damaged area * Suture the ArtiFascia® in place * Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision. Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results.
Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use