Prevention of cerebrospinal fistulae and reduction of epidural scar with new surgical hemostat device in a porcine laminectomy model.

Study Design: In a porcine laminectomy model, a standard dural/arachnoid incision was made and tested for cerebrospinal fluid leak after material application. Sites were graded for scar formation and healing response at 3 weeks.

Objective: This study compares effectiveness of CoStasis, Tissucol, and suture for prevention of cerebrospinal fluid leaks and epidural scar formation after spinal dural incisions.

Summary Of Background Data: Cerebrospinal fluid leaks following cranial and spinal surgery are potentially serious complications. Epidural scar formation is exacerbated by improper control of hemostasis. A hemostatic agent with dural sealant properties may be advantageous.

Methods: Total laminectomy was performed at three levels in seven pigs. At each level, a uniform 1.5 cm incision was made in the dura and arachnoid. A single suture was placed to approximate the edges and sites were treated with one of three methods: CoStasis, Tissucol, or no treatment. At sacrifice, 3 weeks later, epidural scar was graded, pressure testing of some sites was done, and tissue for histologic sections was harvested.

Results: CoStasis and Tissucol produced immediate dural sealing when the valsalva maneuver was applied. One suture-only site leaked. At sacrifice, all sites were sealed. CoStasis and Tissucol had less scar formation than control sites. Pressure testing results were similar at CoStasis and Tissucol sites.

Conclusion: CoStasis and Tissucol have comparable effectiveness in sealing CSF leaks immediately and at 3 weeks after complete laminectomy. CoStasis demonstrated comparable performance to Tissucol with less epidural scar formation than primary suture alone.