• Spine · Sep 2005

    Randomized Controlled Trial Multicenter Study

    Efficacy and safety of a novel moldable, resorbable, and degradable sealant of bone surfaces for hemostasis after bone graft harvesting from the iliac crest.

    • Andreas Pingsmann, Ruth Blatt, Steffen Breusch, Christian Jürgens, Roland Thietje, Andreas Krödel, Wolfgang Zinser, Ivo Michiels, Fritz U Niethard, Christopher Niedhart, Katrin Renzing-Köhler, and Hans-Joachim Pfefferle.
    • Department of Orthopaedics, Essen University Medical School, Darmstadt, Germany. a.pingsmann@biberburg.de
    • Spine. 2005 Sep 1; 30 (17): 1911-7.

    Study DesignA prospective, controlled, open, randomized multicenter study.ObjectiveThe study's objective was to demonstrate equivalence of a novel, moldable, resorbable, and degradable synthetic polymer (Bone Seal) compared with a collagen fleece (Lyostypt) in efficacy and safety for topical hemostasis after iliac crest bone graft harvesting.Summary Of Background DataHarvesting cortico-cancellous bone from the iliac crest is a well established procedure in orthopedic and particularly in spine surgery. It is associated with significant morbidity at the donor site where hematoma formation may cause impaired wound healing and infections in up to 10% of cases.MethodsA total of 112 patients were included in the safety analysis. Safety was determined by a compound wound healing score and the incidence of adverse clinical effects. One hundred and eight patients were studied for equivalence in efficacy using a compound bleeding score. The handling properties and the application to the bone surface of either device were measured with two additional compound scores.ResultsThe mean bleeding scores in the final analysis was 4.5 +/- 1.3 for the Bone Seal group and 4.2 +/- 1.3 for the collagen fleece group. Bone Seal was better applicable to the bleeding bone surfaces than the collagen fleece, even though its handling was more complicated. Wound healing and the incidences of adverse clinical events were comparable in either study group.ConclusionsBone Seal is an effective and safe hemostatic material for sealing bleeding bone surfaces after iliac crest bone graft harvesting. By virtue of its hemostatic efficacy, Bone Seal is preventive for wound healing disorders.

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