Adherus Dural and Spinal Sealant as Adjuncts to Sutured Dural Repair in a Canine Lumbar Durotomy Repair Model

The objective of this GLP study was to evaluate the safety and effectiveness of Adherus Dural Sealant and Adherus Spinal Sealant when used to achieve watertight dural closure in a canine lumbar durotomy repair model. Another important objective of this study was to determine whether Adherus Dural and Adherus Spinal Sealants would inhibit the formation of peridural fibrosis and dural adhesions as normal healing occurred. The formulations were easy to apply, setting in the expected time frame to form an approximate 2 mm hydrogel film over the durotomy site. Application of Adherus Dural Sealant or Adherus Spinal Sealant provided 100% water-tight closure at time of surgery, as well as at four or five days, two months and four months post-operatively. There were no adverse test articlerelated effects in clinical observations, body weight, food consumption, physical or neurological parameters, clinical pathology parameters, CSF total cell count or chemistry parameters during this study. In addition, there was no histopathological evidence that application of Adherus Dural Sealant or Adherus Spinal Sealant had any adverse effects on the adjacent tissues, including the spinal cord and spinal nerve roots. Furthermore, the formulations did not appear to impede healing of the surgical site. Adherus Dural and Adherus Spinal Sealant, in general, significantly limited dura adhesions at both the two month and four month necropsy intervals. Peridural fibrosis and dura thickening/fibrosis was also reduced in animals that received Adherus Dural or Spinal treatment over that in control animals which did not receive either of the test articles.