TerminatedNot Applicable

Efficacy of Suction Enabled Retraction Device

Stopped: Resources no longer available

United States20 participantsStarted 2017-06-20

Plain-language 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.

Who can participate

Age range22 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Estimated Blood Loss

Timeframe: 1.5 hours

Trial details

NCT IDNCT03160170

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-31

Results submitted2019-04-23

View on ClinicalTrials.gov More Surgical Blood Loss trials