Adherus Dural Sealant as an Adjunct to Sutured Dural Repair in a Canine Cranial Durotomy Repair Model

SUMMARY: The objective of this study was to evaluate the safety and effectiveness of Adherus Dural Sealant when used as an adjunct to sutured closure in a canine durotomy repair model. The effectiveness of dural repair was evaluated at time of surgery, one week post surgery and again at approximately six months post surgery by pressure testing. The safety and endurance of the test article was evaluated over approximately six months using magnetic resonance imaging, clinical evaluations, clinical pathology, and histopathology. During pressure testing at all specified time points, Adherus Dural Sealant provided 100% water-tight closure. None of the Adherus Dural Sealant-treated incisions leaked at intracranial pressures up to 50 mmHg. MRI scans obtained at two to four days post surgery and monthly thereafter showed the test material to be clearly visible in all imaging sequences (T2, FLAIR, T1, and T1 with contrast). The test article continued to be visible, although clearly degrading, through the three month scan, was barely discernible in a portion of the scans at four months, and not present in the five and six month scans (T2 images). Adherus Dural Sealant was well-tolerated and none of the treated animals experienced test article related clinical signs after surgery. There were no test article related changes in body weight, food consumption, neurological/physical examination parameters, and clinical pathology parameters. Histopathologic evaluations indicate that there were no unanticipated morphologic changes associated with a single topical administration of Adherus Dural Sealant to a durotomy site in beagle dogs at eight days or six months post surgery.