Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
Condition: Operation Site Bleed
MeSH terms: Thrombosis
Intervention: Thrombi-Gel
Intervention description: Applicaton of Hemostatic product during surgery
Intervention MeSH terms: Thrombin
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemostatic products; Surgical hemostasis; Thrombi-gel; Gelatin Sponge; Time to hemostasis

Summary:

      This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial
      to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.

      Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of
      care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio.
      Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated
      with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin.
      All study data will be analyzed according to the subjects' assigned randomization group
      assignment, regardless of the treatment actually delivered.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is 18 years of age or older

          2. The subject is undergoing an orthopedic/spinal, general, cardiac, hepatic, or vascular
             surgical procedure (neurosurgical, ophthalmic or urological procedures must be
             excluded)

          3. The subject is willing and able to provide appropriate informed consent

          4. The subject is willing and able to comply with the requirements of the study protocol,
             including the predefined follow-up evaluations

        Inclusion criteria to be determined during the surgical procedure:

        1. The subject has an intraoperative bleeding site which the surgeon is unable or unwilling
        to easily control with conventional methods (cautery, sutures)

        Exclusion Criteria:

          1. The subject is known or suspected to be pregnant (verified in a manner consistent with
             institution's standard of care), or is lactating

          2. The subject has a known allergy to bovine derived products or any other materials used
             in the Thrombi-Gel product

          3. The subject has an active infection at the surgical site

          4. The use of hemostatic agents are contraindicated for the subject

          5. The subject has a known bleeding disorder (including thrombocytopenia [< 100,000
             platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)

          6. The subject has received antibiotic solutions/powders at the intended application site

          7. The subject has had surgery at the intended application site ≤ 6 months before the
             current surgical procedure

          8. The subject is unavailable for follow-up

          9. The subject is currently participating in another investigational device or drug trial

         10. The subject has previously participated in this trial (Protocol 0307) or the
             Thrombi-Paste trial (Protocol 0507)