TissueLink Study During Multi-Level Spine Surgery
Condition: Low Back Pain
MeSH terms: Low Back Pain
Intervention: Tissuelink device
Intervention description: Tissuelink device plus Unipolar electrocautery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: efficacy; hemoglobin; spine

Summary:

      The overall objective of the investigators research is to test the clinical efficacy of the
      TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin
      loss intraoperatively. This is a prospective, randomized investigation that will be performed
      at Duke University Medical Center (DUMC). The overall goal of this study is to evaluate the
      efficacy of Tissue Link HemoSealing system in minimizing hemoglobin loss preoperatively,
      intraoperatively and postoperatively for patients undergoing multilevel elective spinal
      surgery. Not greater than eighty patients scheduled for elective, multi-level decompression
      and fusion spinal surgery with Dr. William Richardson will be randomized into two groups.
      Unipolar electrocautery will be used for intraoperative coagulation in one group and the
      Tissuelink device plus Unipolar electrocautery in the other. These are frequently performed
      cases with significant blood loss but otherwise low morbidity/mortality that would benefit
      from more effective intraoperative coagulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18 years and older

          -  Sex: Both males and females will be included

          -  Patient has a Body Mass Index (BMI) <40

          -  Patient is willing and able to cooperate

          -  Patient is in stable health and cleared for surgery

          -  Patient is a candidate for elective multilevel posterior lumbar compression and fusion
             spinal surgery at least two or greater lumbar level involvement

          -  Patient has completed the Informed Consent Form

        Exclusion Criteria:

          -  Patient is unable or unwilling to comply with the entire study protocol

          -  Patient has a previously diagnosed coagulopathy

          -  Patient has preoperative hemoglobin <11 g/dL

          -  Patient has a Prothrombin Time and International Normalized Ratio (PT/INR) >1.3

          -  Patient has a Partial Thromboplastin Time (PTT) >40

          -  Patient has a platelet count <100k

          -  Patients will also be excluded if taking non-aspirin medications producing a bleeding
             diathesis undetectable by screening labs such as clopidogrel or ticlopidine within
             seven days of surgery or valproic acid (associated with thrombocytopenia)

          -  Trauma patients are excluded

          -  Patient is a poor compliance risk, i.e., history of ethanol, drug abuse

          -  Severe cardiac disorder requiring special fluid management protocols

          -  Patients with acute myocardial infarction and/or acute angina

          -  Patient is on Plavix or other long term anti-coagulation including aspirin (ASA) or
             other nonsteroidal antiinflammatory drugs (NSAIDs) may be included provided their
             medications are discontinued a minimum of 7 days prior to surgery