The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
NCT ID: NCT00990288
Last Updated: 2017-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
196 participants
INTERVENTIONAL
2007-10-31
2010-08-31
Brief Summary
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Detailed Description
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Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.
As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hemostatic Matrix
2 vials of Floseal applied once at the end of surgery
Hemostatic Matrix
FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Control
No intervention.
No interventions assigned to this group
Interventions
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Hemostatic Matrix
FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* No allergies to cow meat (bovine allergies
* No history of bleeding disorders
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Mark P Figgie, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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Other Identifiers
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26078
Identifier Type: -
Identifier Source: org_study_id