Introduction: A novel fibrin dressing (NFD) is a highly efficacious hemostatic agent in vascular, solid organ and bone bleeding. The safety and performance of the NFD to provide a watertight seal of the dura in a caprine spinal CSF leak model was examined in the present study.
Methods: After lumar laminectomy the dura was incised 4-5mm CSF leakage was confirmed. A NFD dressing designed for intraspinal use was applied with pledget for 2 minutes. After 5 minutes the pledget was removed and a Valsalva maneuver was performed. If leakage occurred the procedure was repeated. If leakage continued, the durotomy was closed with a running silk suture.
The goats were survived for 30 days and then euthanized. The wound was inspected for the presence of a pseudomeningocoele. The thecal sac was injected with methylene blue to a pressure of 200cm was used while the durotomy site was observed. The entire thecal sac and contents was then removed and processed for histopathological examination.
Results: The durotomies of 4/5 goats were sealed after initial application of one or two NFD dressings. A fifth goat continued to leak CSF with Valsalva maneuver following the second NFD dressing and required suture repair. None of the five goats had developed a pseudomeningocoele. All five goats had developed normal fibrosis at the surgery site from a gross observation. All five of the repairs withstood pressure of greater than 200cm without leakage.
Conclusions: The NFD sealed 80% of the dural injuries with Valsalva pressures. The seal held pressures of greater than 200cm 30 days following applications. Histopathology did not demonstrate any residual dressing at the site of the injury.
Patient Care: Control of CSF leak from spinal durotomies will reduce morbidity and costs associated with spine surgery
Learning Objectives: A fibrin dressing that leaves no residual material is effective at sealing spinal durotomies.