Use of Spinal Sealant System During Spinal Surgery
Condition: Spine Surgery; Excessive Repair; Spinal Cord Injuries; Complication of Surgical Procedure
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural
           repair compared with standard of care methods (control) to obtain watertight dural
           closure intraoperatively in patients undergoing spinal surgery.

        2. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural
           repair compared with standard of care methods (control) to obtain watertight dural
           closure in patients undergoing spinal surgery up to 90 days post-procedure.
    

Detailed description: 
      The CSF provides a liquid cushion for the brain and spinal cord. The dura holds in the CSF.
      In order to do spinal surgery, the doctor will cut an opening in the dura. At the end of
      surgery, the dura must be sealed in order to keep the CSF from leaking out. The doctor will
      close the dura with stitches and also a piece of tissue taken from another place on your
      body, to help close the opening. Other standard sealant methods have included the use of
      Oxicel, Gelfoam, or fibrin glue, but these methods were not designed for closing the dura.

      Before you can start treatment on this study, you will have what are called "screening
      tests." These tests will help the doctor decide if you are eligible to take part in this
      study. Your doctor will see you within 30 days before your operation. At this visit, your
      medical history will be recorded, and you will be asked questions about any other operations
      you have had in the past. You will have a complete physical exam, including measurement of
      vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and
      weight. You will have a sample of your blood (about 2 tablespoons) collected for kidney and
      liver function tests to make sure they are functioning properly. You will also be asked to
      fill out 2 questionnaires about your health, daily activities, and back pain. The
      questionnaires will take about 20 to 30 minutes to complete. Women who are able to have
      children must have a negative blood pregnancy test.

      If you are found to be eligible to take part in this study, you will be randomly assigned (as
      in the toss of a coin) to one of 2 treatment groups. Participants in one group will receive
      the Spinal Sealant. You have a 2 out of 3 chance of being randomly assigned to the spinal
      sealant group. Participants in the other group will receive other standard methods such as
      the closing of the dura with stitches. However, you will not know which one of the two
      treatments you receive. Also, (if needed) a piece of your muscle, fat, or other soft tissue
      may be taken from another place on your body to help seal the opening. Doctors may also use
      Oxicel, Gelfoam, or fibrin glue to help with the sealing of the dura .

      After your already scheduled spinal surgery, your doctor will try to close the opening in the
      dura, which may be done with stitches alone or, if needed, stitches and a piece of your
      muscle, fat, or other soft tissue taken from another place on your body. After this try, if
      there is still some CSF leaking from the dura, you will be assigned to one of the 2 groups
      for treatment. If you do not have a CSF leak that needs treatment, you will not be able to
      take part in this study, and you will not have to come back for any study visits.

      Participants assigned to the first group will receive treatment with the Spinal Sealant,
      which will be sprayed over their stitches to close the opening in their dura. The Spinal
      Sealant is made of 2 plastic-type liquids. When mixed together, a gel is formed that is
      mostly made up of water. The gel looks and feels sort of like a soft contact lens. After the
      doctor tries to seal the opening in the dura, the Spinal Sealant is then sprayed over the
      stitches. It acts like a thin, stretchy covering to help stop the CSF from leaking out
      through the stitches until the area has properly healed on its own. It is blue-colored, so
      that the doctor can see where it has been sprayed. Within 1 to 2 months, the gel is naturally
      broken down by the body and is removed through the urine.

      Participants assigned to the second group will be treated with the doctor's choice of other
      standard treatments to close the opening in their dura. You will not know which group you
      were assigned to until after the end of your study participation (about 90 days).

      While you are still in the hospital (within 7 days after your operation), you will have a
      physical exam, and your doctor will do a clinical test to check for any CSF leaks. Also, you
      will have a sample of your blood (about 2 tablespoons) drawn for kidney and liver function
      tests.

      For follow-up, you will be seen by your doctor at about 30 days and again at about 90 days
      after your operation. It will be very important for you to return to see your doctor at your
      scheduled follow-up visits, even if you are feeling fine. At the follow-up visits, your
      doctor will perform a physical exam and check to see how your dura wound is healing and if
      there is any CSF leakage. You will have a sample of your blood (about 2 tablespoons)
      collected for kidney and liver function tests. You will also be asked to fill out 2
      questionnaires about your health, daily activities, and back pain. The questionnaires will
      take about 20 to 30 minutes to finish.

      Your participation in this study will be over after your 90-day follow-up visit.

      THIS IS AN INVESTIGATIONAL STUDY. The Spinal Sealant has been authorized by the FDA for use
      in research only.

      About 158 patients will take part in this multicenter study. Between 15 to 20 participants
      will be enrolled at M. D. Anderson.
    

Intervention name(s): Spinal Sealant; Standard Methods of Closing of the Dura
Intervention type(s): Device; Procedure
Intervention description(s): Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.; Standard methods such as the closing of the dura with stitches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spinal Sealant; Spinal Sealant System; Dural Repair; Spinal Surgery