Background: Cancellous bone bleeding (CBB) is a significant source of blood loss in spine and pelvis surgery. Current hemostatic methods are either ineffective or interfere with bone healing. A novel fibrin dressing (NFD) controls arterial, solid organ, and CBB in various species. The purpose of this clinical study was to determine the safety and performance of the NFD at controlling CBB.
Methods: Forty patients were enrolled at 9 centers in the UK, Norway and India. In each country Ethics Committee approvals were obtained prior to the study. This was a Level IV single-arm study of patients who met the inclusion eligibility criteria. The follow-up period was 6 weeks. The primary endpoint was control of bleeding at 3 min. Secondary endpoints were control of bleeding at 6 min, as well as clinical and laboratory criteria. Anatomical sites (AS) included posterior spinal fusion (PSF), iliac crest graft (ICG), and pelvic osteotomy (PO). Intraoperatively, the surgeon assessed the severity of CBB (pulsatile, flowing, oozing or none) and applied the dressing for 3 min. Bleeding was then assessed again and if it was not controlled (oozing or none) a second dressing was applied for an additional 3 min. For bleeding not controlled after the second dressing application the surgeon used an alternative method. Patients were assessed at 24 h and 6 weeks clinically (for hematoma, allergic reaction, etc.) and with lab analysis, including CBC, PT, aPTT and INR.
Results: All 40 patients completed the 6 week follow up. Twenty-three patients had PSF, 14 ICG and 3 PO. The dressing was used on a second AS in 11 of these patients for a total of 51 AS tested. Of the 51 treated AS, bleeding was controlled at 3 min in 41/51 (80.4%) and 6 min in 48/51 (94.1%). Three patients required alternative treatment. Bleeding in all 3 of the PO patients, the most vigorous bleeding, was controlled with the dressing. Adverse events (AE) considered to be "possibly device-related" occurred in 4 patients (13.3%).
Conclusions: This Phase I clinical trial demonstrated the safety and efficacy of this novel fibrin dressing, SurgiClot in cancellous bone bleeding. A randomized, controlled FDA trial currently is underway.
Birender Balain, Niall Craig, Kanna Gnanalingham, Sanjeev Madan, Hemant Sharma, Guy Wynne-Jones, John Hoseth, Lian Øsytein, Vidar Punsvik, Sukumar Sura, Rodolfo Padua and Timothy Floyd*
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