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

The objective of this study was to evaluate the safety and effectiveness of Adherus Dural Sealant when used as an adjunct to sutures in dural closure in a canine durotomy repair model. The effectiveness was evaluated at time of surgery, Day 8 and again at approximately 6 months 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 at 2 to 4 days post surgery and monthly thereafter showed the test material clearly visible in all images (T2, FLAIR, T1, and T1 with contrast) two to three days following surgery. The test article continued to be visible, although degrading, through the 3 month scan, barely discernible in a portion of the scans at 4 months, and not present in the 5 and 6 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 morphologic changes associated with a single topical administration of Adherus Dural Sealant to a durotomy site in beagle dogs at seven days post surgery or at six months post surgery.