Hemostasis and Safety of a Novel Fibrin Dressing Versus Standard Gauze in Bleeding Cancellous Bone in a Caprine Spine Surgery Model

Publication date: September 2017
Source:Spine Deformity, Volume 5, Issue 5
Author(s): C. Timothy Floyd, Rodolfo A. Padua, Curtis E. Olson
BackgroundDecorticated bone is a significant source of blood loss in scoliosis surgery. Current hemostatic methods include packed gauze (GS), physical barriers such as bone wax, and xenograft collagen-based materials. We assessed the safety and efficacy of a novel fibrin dressing (dextran-thrombin-fibrinogen [DTF]) compared to GS. This dressing comprises lyophilized thrombin and fibrinogen embedded in an elastic electrospun nanofiber dextran matrix.PurposeThe study tests the hypothesis that DTF is more efficacious than GS in control of bleeding from cancellous bone.Study DesignA preclinical Good Laboratory Practices (GLP) study.MethodsWe enrolled 10 goats that were followed for 28 ± 1 days. Each animal was randomly assigned to the test or control group. Both test and control animals had 4 cancellous bone injuries. Test animal injuries were treated with DTF, whereas standard GS was used to control bleeding in the control animals. Bleeding at the bone injury site was characterized as either none, oozing, flowing, or pulsatile and was assessed at 4 and 8 minutes after dressing application. Goats were survived 28 ± 1 days and then necropsied.ResultsApplication of the fibrin dressing to bleeding cancellous bone, both posterior spinal lamina, and iliac crest graft sites, resulted in control of bleeding within 4 minutes at all injury sites. Eighty percent of control injury sites continued to bleed after 8 minutes and required application of bone wax to control bleeding. There were no differences in prothrombin time, partial thromboplastin time, or fibrinogen levels between test and control animals at 1 or 28 days. We observed no adverse histologic reactions at 28 days.ConclusionThe fibrin dressing is an efficacious and safe method of controlling blood loss from cancellous bone in a spine surgery model.



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