Efficacy of Suction Enabled Retraction Device

Stopped early · Not applicable

Conditions studied: Surgical Blood Loss, Spinal Surgery

In brief

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.

Key facts

Study ID

NCT03160170

Run by

University of Miami

People needed

20

Starts

2017-06-20

Expected to finish

2018-12-28

Last updated by the study team

2019-05-15

Who can join

Age: 22 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jackson Memorial Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.