Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin (Control)

• The primary objective of this investigation is to gather information to support the effectiveness of Thrombi-Gel as compared to a gelatin sponge (Gelfoam) plus thrombin as an adjunct to hemostasis in multi-specialty surgical settings. [ Time Frame: 30 day, 60 day ] [ Designated as safety issue: No ]
  

• Effectiveness: Device success (defined as the percentage of first bleeding site applications for which hemostasis was obtained within 6 minutes of study device application without the need for adjunctive treatment) [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  
• Effectiveness: Hemostatic handling characteristics (surgeon's questionnaire) [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  
• Safety: Incidence rate of device-related adverse events [ Time Frame: Procedure, 30 Day, 60 Day ] [ Designated as safety issue: Yes ]
  
• Safety: Immunological testing for factor Va antibodies and coagulation parameters [ Time Frame: 30 day, 60 day ] [ Designated as safety issue: Yes ]
  

This is a prospective, randomized, multi-center investigation with a minimum of seventy five (75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel product as an absorbable hemostat in the surgical patient population.

Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular surgical procedures should be considered for this investigation. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she is unable or unwilling to easily control due to failure or impracticality of conventional methods (sutures and/or cautery), the subject may be enrolled and randomized to receive either the investigational or control treatment. If the subject has multiple bleeding sites, each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat. However, only the first site treated will be used to determine study objectives. All subjects will be followed through their hospitalization.

A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to determine the long-term effectiveness of the hemostatic treatment received, incidence of late adverse events, and interim immunologic response to the study treatment device. Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody development, coagulation, and Factor Va testing. Blood samples will be sent to independent labs for analysis.

From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals. The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen (15) sites.