Transparent equine collagen biomatrix as dural repair. A prospective clinical study.

Abstract: Numerous materials have been used to replace defects in the dura mater as result of neurosurgical and spinal procedures. Tissudura is a biomatrix made of cross-linked equine collagen fibrils, mainly of the interstitial type I. The specially engineered dura-like layered structure provides a non porous primary water tight structure, is transparent and allows verification of the efficacy of cerebral hemostasis. Methods: A consecutive series of patients between 18 years and 75 years of age were prospectively enrolled from three separate European institutions between May 2007 and February 2008. All patients underwent elective cranial or spinal surgery and required implantation of a dural substitute. We assessed the efficacy and safety of the collagen biomatrix as a dural substitute, intraoperatively and postoperatively, with a median follow-up 4.3 months. Results: Fifty-six patients had cranial surgery, four patients underwent a spinal operation. Surgical cranial approaches included supratentorial procedures in 45 patients and posterior cranial fossa exploration in 11. At 7-days follow-up, a CSF leak was reported in one patient after excision of a vestibular schwannoma and in another with a thoracic vertebral body fracture and spinal cord transaction. Neither needed reoperation. A subgaleal fluid collection in two patients who had been treated for a supratentorial lesion resolved after tapping. The transparency of the implant was beneficial to inspect the underlying surgical area at the end of the procedure in one patient in whom a hematoma formed after secondary to oozing glioblastoma removal. Of the 56 patients who reached the 3-month follow-up, none had a CSF leak, meningitis, wound infection or fistulae. No duroplasty failure was observed. In one patient who underwent reoperation after 40 days, histopathological findings revealed the replacement of the implant by ingrowth from the original dura. Conclusions: Tissudura is simple, efficacious and safe to use. The use of fibrin glue reduces suturing and facilitates the implantation of the collagen biomatrix. Its transparency makes it unique and beneficial in inspection of the underlying area of operation. The lack of adverse reaction indicates that this graft may be used as an option in the repair of dural defects.