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TissueLink Study During Multi-Level Spine Surgery

This study has been completed.
Sponsor:
Collaborator:
Salient Surgical Technologies
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01300559
First received: February 3, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Device: Tissuelink device
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: April 2006
Study Completion Date: August 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300559

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Salient Surgical Technologies
Investigators
Principal Investigator: Steven E Hill, MD Duke University
Study Chair: William J Richardson, MD Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01300559     History of Changes
Other Study ID Numbers: Pro00016175
Study First Received: February 3, 2011
Results First Received: October 31, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
efficacy
hemoglobin
spine

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013