Efficacy of Suction Enabled Retraction Device

Not Applicable

Terminated

• Conditions: Surgical Blood Loss; Spinal Surgery
• Interventions: Device: SISTER device

• Registration Number: NCT03160170
• Lead Sponsor: University of Miami

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Study Start: 2017-06-20
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-28
• Status Verified: 2019-04
• Results First Submitted: 2019-04-23
• Results First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Results First Posted: 2019-05-15
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of Cobb device	SISTER device	Use of SISTER device during surgery

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss	1.5 hours	Amount of blood loss from incision time to screw placement

Secondary Outcome Measures

Name	Time	Method
Rate of Clogging	1.5 hours	Average number of times the suction tip of the device had to be unclogged
Time of Exposure	1.5 hours	Length of operation in minutes

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States