use of a novel fibrin dressing on spinal cerebrospinal ...seal of the dura in a caprine spinal csf...

Use of a Novel Fibrin Dressing on Spinal Cerebrospinal Fluid Leaks Charles T Floyd MD; Rudolfo A Padua PhD; Curtis E Olson PhD St. Teresa Medical, Inc., Eagan, MN 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 with a #11 scalpel. CSF leakage was confirmed by direct visualization and by Valsalva maneuver (20cm water for 10 sec). A NFD dressing designed for intraspinal use was applied with pledget providing slight pressure for 2 minutes. After a total of 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 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. In this particular animal, the NFD adhered to the pledget rather than to the dura, so it did not remain in situ. None of the five goats had developed a pseudomeningocoele. All five goats had developed normal fibrosis at the surgery site based on gross observation. All five of the repairs withstood pressure of greater than 200cm without leakage. Histopathology confirmed the presence of normal fibrosis with minimal inflammatory reaction. Minimal giant cell macrophages were observed and we saw no residual foreign body material. Conclusions The NFD sealed 80% of the dural injuries. We observed no leakage of CSF either spontaneously or with Valsalva pressures and this appeared to be a permanent repair after 30 days. The dressing generally is more adherent to tissue than to gauze and is simple to use with no preparation necessary. Our pre-clinical studies show that this dressing controls CSF leaks from cranial and spinal dura and is useful as an autonomous, translucent patch that adheres tenaciously to the dura, allowing the surgeon to continue to work with impunity from dislodgement and recurrent leak. We believe the NFD will be an important tool to control CSF leak for spinal surgery. Learning Objectives A fibrin dressing that leaves no residual material is effective at sealing spinal durotomies. References Floyd CT, Rothwell SW, Martin R, Risdahl J, Olson CE. A salmon thrombin-fibrinogen dressing controls hemorrhage in a swine model compared to standard koalin-coated gauze. Journal of Special Operations Medicine, 12(1): 49-55, 2012. Floyd CT, Rothwell SW, Risdahl J, Martin R, Olson C, Rose N. Salmon thrombin-fibrinogen dressing allows greater survival and preserves distal blood flow compared to standard kaolin gauze in coagulopathic swine with a standardized lethal femoral artery injury. Journal of Special Operations Medicine, 12(2): 16-26, 2012. Floyd CT, Padua RA, Olson CE. Hemostasis and safety of a novel fibrin dressing versus standard gauze in bleeding cancellous bone in a caprine spine surgery model. Spine Deformity, Accepted with publication pending.

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Page 1: Use of a Novel Fibrin Dressing on Spinal Cerebrospinal ...seal of the dura in a caprine spinal CSF leak model was examined in the present study. Methods After lumar laminectomy the

Use of a Novel Fibrin Dressing on Spinal Cerebrospinal Fluid LeaksCharles T Floyd MD; Rudolfo A Padua PhD; Curtis E Olson PhD

St. Teresa Medical, Inc., Eagan, MN

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.

MethodsAfter lumar laminectomy the dura was incised 4-5mm with a #11 scalpel. CSF leakage wasconfirmed by direct visualization and by Valsalvamaneuver (20cm water for 10 sec). A NFD dressingdesigned for intraspinal use was applied withpledget providing slight pressure for 2 minutes.After a total of 5 minutes the pledget was removedand a Valsalva maneuver was performed. Ifleakage occurred the procedure was repeated. Ifleakage continued, the durotomy was closed with arunning silk suture.The goats were survived for 30 days and theneuthanized. The wound was inspected for thepresence of a pseudomeningocoele. The thecal sacwas injected with methylene blue to a pressure of200cm while the durotomy site was observed. Theentire thecal sac and contents was then removedand processed for histopathological examination.

ResultsThe durotomies of 4/5 goats were sealed after initialapplication of one or two NFD dressings. A fifthgoat continued to leak CSF with Valsalva maneuverfollowing the second NFD dressing and requiredsuture repair. In this particular animal, the NFDadhered to the pledget rather than to the dura, so itdid not remain in situ.None of the five goats had developed a pseudo-meningocoele. All five goats had developed normalfibrosis at the surgery site based on grossobservation. All five of the repairs withstoodpressure of greater than 200cm without leakage.Histopathology confirmed the presence of normalfibrosis with minimal inflammatory reaction.Minimal giant cell macrophages were observed andwe saw no residual foreign body material.

ConclusionsThe NFD sealed 80% of the dural injuries. Weobserved no leakage of CSF either spontaneously orwith Valsalva pressures and this appeared to be apermanent repair after 30 days. The dressinggenerally is more adherent to tissue than to gauzeand is simple to use with no preparation necessary.Our pre-clinical studies show that this dressingcontrols CSF leaks from cranial and spinal dura andis useful as an autonomous, translucent patch thatadheres tenaciously to the dura, allowing thesurgeon to continue to work with impunity fromdislodgement and recurrent leak. We believe theNFD will be an important tool to control CSF leak forspinal surgery.

Learning Objectives

A fibrin dressing that leaves no residual material is

effective at sealing spinal durotomies.

ReferencesFloyd CT, Rothwell SW, Martin R, Risdahl J, Olson CE. A salmonthrombin-fibrinogen dressing controls hemorrhage in a swinemodel compared to standard koalin-coated gauze. Journal ofSpecial Operations Medicine, 12(1): 49-55, 2012.

Floyd CT, Rothwell SW, Risdahl J, Martin R, Olson C, Rose N.Salmon thrombin-fibrinogen dressing allows greater survival andpreserves distal blood flow compared to standard kaolin gauze incoagulopathic swine with a standardized lethal femoral arteryinjury. Journal of Special Operations Medicine, 12(2): 16-26,2012.

Floyd CT, Padua RA, Olson CE. Hemostasis and safety of a novelfibrin dressing versus standard gauze in bleeding cancellous bonein a caprine spine surgery model. Spine Deformity, Accepted withpublication pending.