TissueLink Study During Multi-Level Spine Surgery

January 3, 2013 updated by: Duke University

Efficacy of the TissueLink Coagulation System in Reducing Hemoglobin Loss 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Aquamantys
No Intervention: No treatment
Unipolar electrocautery without Tissuelink device will be used in this arm of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Measurement g/dl
Time Frame: At the end of surgery
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.
At the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Salient Surgical Technologies

Investigators

  • Principal Investigator: Steven E Hill, MD, Duke University
  • Study Chair: William J Richardson, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00016175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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