TissueLink Study During Multi-Level Spine Surgery
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy of the TissueLink Coagulation System in Reducing Hemoglobin Loss During Multi-Level Spine Surgery|
- Hemoglobin Measurement g/dl [ Time Frame: At the end of surgery ] [ Designated as safety issue: No ]The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.
|Study Start Date:||April 2006|
|Study Completion Date:||August 2012|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment Group
Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
Device: Tissuelink device
Tissuelink device plus Unipolar electrocautery
Other Name: Aquamantys
No Intervention: No treatment
Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
Very little research exists in the use of TissueLink HemoSealing device in spinal surgery. One retrospective study by Snyder et al evaluated hemostatic efficacy of this technology in children undergoing surgery for spinal fusion and instrumentation. Although the study reported no statistically significant difference in transfusion rates, there was a reduction in amount of blood transfused and operative time which was attributed to hemostatic efficacy in comparison with conventional wound management during surgery. The surgeons also reported a clearer operative field, improving visualization during surgery. Finally, the reduction in operative time which they suggested might be due to the use of this new device may reduce other complications by diminishing overall anesthesia exposure and blood product transfusions. From this initial retrospective study, the authors concluded that the use of the TissueLink HemoSealing device in spine surgery may be an effective tool in control of intra- and post-operative blood loss and may significantly reduce blood related and operative complications. More rigorous research needs to be done to evaluate the efficacy of the TissueLink HemoSealing device in hemostasis in the area of spine surgery.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Steven E Hill, MD||Duke University|
|Study Chair:||William J Richardson, MD||Duke University|