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.