The following videos illustrate the performance of PlexiClot™ Absorbable Hemostat in in vivo trials. All the trials were conducted in porcine models as this is the standard large animal model used to evaluate hemostats. Pigs are ‘close to humans’ in the way that they form blood clots and hemostasis.
The first video, labeled “Porcine Liver Abrasion”, demonstrates one of the types of bleeding that surgeons encounter in neurosurgery, an oozing bleeding. In this situation, one cannot clearly identify a source of the bleeding such as a ruptured vessel. If the source of the bleeding could be identified and isolated, electrocautery would be used to achieve hemostasis and a permanent stable clot. To achieve hemostasis in this situation, surgeons typically use an absorbable hemostat. The standard of care in cranial surgery is the use of a Gelfoam® dressing soaked in thrombin and maintained manually onto the site with ‘standard pressure’. This technique often takes 4-6 minutes to be effective, with a moderate success rate. PlexiClot performs well in this situation, achieving hemostasis much more quickly and with a much higher and consistent success rate, without manual compression. Success was measured both visually and with histology and SEM. Neurosurgery is one of first clinical targets for PlexiClot.
The second video, labeled “Porcine Liver Biopsy”, demonstrates bleeding in a deeper surgical wound in a pig liver. This bleeding can be characterized as moderate flow, high pressure bleeding. PlexiClot performed well in this model. The PlexiClot matrix formed in a wet environment, adhered to the margins of the created wound, and quickly stopped bleeding, without manual compression. Success was measured both visually and with histology and SEM.
The third video, labeled “Porcine Liver Laceration”, demonstrated the performance of PlexiClot in a much deeper wound that approximates the type of high flow, higher pressure bleeding found in some surgeries and trauma. PlexiClot performed in this model. The PlexiClot matrix formed in this wet environment and adhered to the margins of the created wound, and quickly stopped the flow of blood, without manual compression. The wound was followed for several minutes before samples were taken for confirmatory histology and SEM.