Clinical Trials

Clinical Safety and Performance
Study in the United Kingdom and Norway

How safe and effective is SurgiCLOT at controlling bone bleeding?

  • 30 patients enrolled
  • Bone sites: 39 sites in spine and pelvis
  • 90% control of bleeding at first site
  • 100% control of bleeding at second site
  • No significant device-related adverse events
  • All surgeons reported SurgiCLOT was “as effective” or “much more effective” than other hemostatic products
  • Conclusion: SurgiCLOT is safe and effective at controlling bleeding compared to other hemostatic products

Clinical Safety and Performance Study in India

How safe and effective is SurgiCLOT at controlling bone bleeding?

  • 10 patients enrolled
  • Bone site: 12 sites in spine
  • 100% control of bleeding at 3 minutes with one application
  • No significant device-related adverse events
  • All surgeons reported SurgiCLOT was “much more effective” than other hemostatic products
  • Conclusion: SurgiCLOT is safe, effective, and “much more effective” at controlling bleeding than other hemostatic products

Pre-Clinical Study of Bone Bleeding treated with SurgiCLOT compared to Standard Gauze

Clinical Question: How effective is SurgiCLOT compared to the standard method of controlling bleeding during spine surgery, packing with cotton gauze sponges?

  • 10 subjects
  • Bone sites: 40 sites in spine and pelvis
  • 100% control of bleeding at 4 minutes with one application of SurgiCLOT
  • 5% control of bleeding at 4 minutes with one application of comparator
  • No significant safety events
  • Conclusion: SurgiCLOT is vastly superior to standard gauze at controlling bone bleeding

Pre-Clinical Study of Performance of SurgiCLOT compared to Dextran-only Dressing

Clinical Question: What is the Primary Mode of Action of SurgiCLOT?

  • 3 subjects
  • Bone sites: 20 sites in spine and pelvis
  • 100% control of bleeding at 2 minutes with one application of SurgiCLOT
  • 40% control of bleeding at 2 minutes with one application of Dextran-only
  • Conclusion: The Dextran component of the SurgiCLOT dressing acts as the primary mode of action of the dressing, with addition of proteins as ancillary action
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