NCT03160170

Efficacy of Suction Enabled Retraction Device

Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 22 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Blood Loss
• Spinal Surgery

Interventions

Type	Name	Description
DEVICE	SISTER device	Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-10-31
• Completion: 2018-12-28
• First posted: 2017-05-19
• Last updated: 2019-05-15
• Results posted: 2019-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study