TissueLink Study During Multi-Level Spine Surgery
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|ClinicalTrials.gov Identifier: NCT01300559|
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Tissuelink device||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of the TissueLink Coagulation System in Reducing Hemoglobin Loss During Multi-Level Spine Surgery|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||August 2012|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300559
|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|