Cancellous Bone Bleeding Clinical Trial
Official title:
A Multicenter Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding
The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.
Patients who require surgery for iliac crest bone graft (ICBG), pelvic osteotomy or spinal
fusion will be screened for this multicenter, prospective, non-randomized, open-label study.
All qualified subjects will be treated with the SurgiClot® haemostatic dressing (a
completely soluble dressing consisting of solid nanofibers of electrospun dextran with
embedded lyophilized human fibrinogen and thrombin proteins).
The safety and performance of the SurgiClot dressing will be evaluated in up to 40 subjects
enrolled in Europe. Subjects will be followed for six weeks after the surgery.
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