Efficacy of Suction Enabled Retraction Device

Study Overview
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Brief Summary
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This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue Elevator & Retractor [SISTER] device to assess: Effects on operative time and efficiency of exposure in open lumbar spine cases. Effect on total blood loss during the exposure part of the operation. Rate of clogging of suction device.

Detailed Description
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The device, Suction-Integrated Surgical Tissue Elevator & Retractor [SISTER], is shaped like a Cobb elevator but also has a hollow core allowing suction tubing to be connected. Thus, a single hand can be used to retract and suction at the same time while the other hand separates soft tissue from the bones with electrocautery. This set up which is proposed to be more efficient will be evaluated in this study.

Official Title
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Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery

Conditions
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Surgical Blood Loss, Spinal Surgery

Intervention / Treatment
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* Device: SISTER device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Patients undergoing lumbar one to sacral one open instrumentation Surgery performed by the Departments of Neurological Surgery and Orthopedics at the University of MIami Miller School of Medicine Exclusion Criteria: Less than 22 years old Procedure does not involve instrumentation Prior lumbar spine surgery involving more than one level BMI less than 20 or greater than 35 Known bleeding conditions ( ex. Factor V Leiden, Von Willebrand) Routinely taking anticoagulation medicine (ex. aspirin 325 mg/day, Plavix) Operative cases where a single surgeon performs both sides of exposure Pregnant women Prisoners Adults unable to consent

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of Cobb device<br>Use of SISTER device during surgery | Device: SISTER device<br>* Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery<br>* Other names: Cobb;|
| No Intervention: Control<br>Standard exposure technique and instruments will be used during surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Blood Loss | Amount of blood loss from incision time to screw placement | 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Exposure | Length of operation in minutes | 1.5 hours | 
| Rate of Clogging | Average number of times the suction tip of the device had to be unclogged | 1.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open lumbar spine surgery, operative time and efficiency, Suction-Integrated Surgical Tissue Elevator and Retractor