Efficacy, Security, and Manageability of Gelified Hemostatic Matrix in Bleeding Control during Thoracic and Lumbar Spine Surgery: FloSeal versus Surgiflo.
BACKGROUND
Accurate hemostasis in surgical practice is critical. The need for optimal atraumatic hemostasis has become compelling in neurosurgery. A simple and safe gelified hemostatic matrix is often used. This prospective study evaluates two different hemostatics, FloSeal (Baxter Healthcare, Deerfield, Illinois, United States) and Surgiflo (Ethicon, Somerville, New Jersey, United States), for bleeding control during spine surgery, considering their efficacy, safety, and ease of use.


METHODS
From January 2012 to December 2013, we recruited 149 patients. Inclusion criteria were age between 25 and 80 years, diagnosis of degenerative or traumatic pathology of the lumbar or thoracolumbar spine, and persistent bleeding not responding to standard hemostatic techniques. All patients underwent laminectomy or laminoarthrectomy, with exposure of the perivertebral venous plexus. Our aim was to stop the bleeding completely in the operative field by application of hemostatic gel. All patients were evaluated during the follow-up period with a clinical and neurologic examination. All patients underwent a computed tomography scan 3 months after the intervention.


RESULTS
We included 149 patients in our study: 98 men and 51 women. Overall, 92 patients were affected by a degenerative condition and 57 by traumatic pathology. A total of 42 patients had anticoagulant and/or antiaggregant therapy preoperatively. In all cases, massive bleeding originated from the epidural venous plexus. FloSeal was used in 86 cases and Surgiflo in 63. A complete hemostasis was achieved in all patients within 3 minutes, 30 seconds and 7 minutes (FloSeal, 5 minutes, 35 seconds ± 52 seconds; Surgiflo, 5 minutes, 32 seconds ± 54 seconds). Statistical analysis did not show any association between coagulation time and hemostatics, age, sex, and the pathology treated. Previous therapy with antiaggregants and/or anticoagulants determined a slight increase in the time of hemostasis without any statistical differences. The clinical and radiological follow-up showed no evidence of postsurgical hematomas.


CONCLUSIONS
Comparative analysis of the two products did not show any relevant differences in terms of efficacy and ease of use or their effectiveness in bleeding control. Their use was valid even in patients who used antiaggregant/anticoagulant drugs preoperatively. Both FloSeal and Surgiflo can be considered good choices for controlling bleeding in spinal surgery.
Department of Neurosurgery, Sapienza University of Rome, Rome, Italy.
Alessandro
A
Landi
Department of Neurosurgery, Sapienza University of Rome, Rome, Italy.
Fabrizio
F
Gregori
Department of Neurosurgery, Sapienza University of Rome, Rome, Italy.
Nicola
N
Marotta
Department of Neurosurgery, Sapienza University of Rome, Rome, Italy.
Roberto
R
Delfini
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D005260:Female; D005781:Gelatin Sponge, Absorbable; D006489:Hemostatic Techniques; D006801:Humans; D007796:Laminectomy / Q000009:adverse effects* / Q000379:methods; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D013904:Thoracic Vertebrae / Q000601:surgery*; D016896:Treatment Outcome
C411004:FloSeal Matrix