TissueLink Study During Multi-Level Spine Surgery

NCT01300559 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00016175
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

efficacy; hemoglobin; spine

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Measurement g/dl

  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

Study Arms (2)

Treatment Group

EXPERIMENTAL

Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.

Device: Tissuelink device

No treatment

NO INTERVENTION

Unipolar electrocautery without Tissuelink device will be used in this arm of the study.

Interventions

Tissuelink device DEVICE

Tissuelink device plus Unipolar electrocautery

Also known as: Aquamantys

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Salient Surgical Technologies: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Hill SE, Broomer B, Stover J, White W, Richardson W. Bipolar tissue sealant device decreases hemoglobin loss in multilevel spine surgery. Transfusion. 2012 Dec;52(12):2594-9. doi: 10.1111/j.1537-2995.2012.03649.x. Epub 2012 Apr 15.

  PMID: 22500572 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

None encountered.

Results Point of Contact

• Title: Steven E. Hill, M.D.
• Organization: Duke University Medical Center

hill0012@mc.duke.edu

681-6614

Study Officials

• Steven E Hill, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• William J Richardson, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 21, 2011
• Study Start: April 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: August 1, 2012
• Last Updated: February 7, 2013
• Results First Posted: February 7, 2013

Record last verified: 2013-01

Locations

US (1)