A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compar… (NCT04145544) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject between the ages of 18-75
✓. Subject is scheduled for an elective cranial surgery with a dural damage that can be completely repaired/closed by a suture-able dural substitute (ArtiFascia device or other commercially available dural substitutes)
✓. Subject has undergone radiographic imaging (such as, MRI) in the past 6 months before enrolment
✓. Surgical wound is expected to be Class I/clean
✓. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
✓. Subject is able and willing to adhere to the required follow-up visits and testing
Exclusion criteria
✕. Pregnant women or interest in becoming pregnant during the duration of the study
✕. Subject has known hydrocephalus
✕. Subject is unable to undergo MRI after the surgery
What they're measuring
1
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging.
✕. Subject's life expectancy is less than 12 months
✕. Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever \> 38.3℃, positive blood culture and/or a positive chest x-ray for acute infectious process
✕. Subject will require use of dural adhesive or sealant
✕. Subject is intended to undergo craniectomy wherein bone flap will not be returned
✕. Subject with suspected low success in wound healing due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other conditions (e.g. severe peripheral vascular disease, long standing steroids treatment)