Efficacy of Suction Enabled Retraction Device

University of Miami

Status: Terminated

Conditions: Surgical Blood Loss; Spinal Surgery

Treatments: Device: SISTER device

Study type: Interventional

Funder types: Other

Identifiers

NCT03160170

20161061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 22 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Use of Cobb device

Experimental group

Description:

Use of SISTER device during surgery

Treatment:

Device: SISTER device

Control

No Intervention group

Description:

Standard exposure technique and instruments will be used during surgery