Surgical Blood Loss Clinical Trial
Official title:
Intraoperative Efficacy of Suction Enabled Retraction Device in Lumbar Spine Surgery
Verified date | April 2019 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jackson Memorial Hospital | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Ludwig Medical Corporation |
United States,
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 |
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