At a glance
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Efficacy of the TissueLink Coagulation System in Reducing Hemoglobin Loss During Multi-Level Spine Surgery
In Brief
A Phase 4 clinical trial evaluating Tissuelink device for Low Back Pain. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Tissuelink device plus Unipolar electrocautery