Efficacy of Suction Enabled Retraction Device

Surgical Blood Loss Clinical Trial

Official title:

Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03160170
• Other study ID #: 20161061
• Status: Terminated
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: April 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 28, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Spinal Surgery
• Surgical Blood Loss

Intervention

Device:
• SISTER device
Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Ludwig Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Blood Loss	Amount of blood loss from incision time to screw placement	1.5 hours
Secondary	Time of Exposure	Length of operation in minutes	1.5 hours
Secondary	Rate of Clogging	Average number of times the suction tip of the device had to be unclogged	1.5 hours