Use of Spinal Sealant System During Spinal Surgery

Completed · Phase 3

Conditions studied: Spine Surgery, Excessive Repair, Spinal Cord Injuries, Complication of Surgical Procedure

In brief

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.

Key facts

Study ID

NCT00458354

Run by

M.D. Anderson Cancer Center

People needed

3

Starts

2006-01-01

Expected to finish

2008-12-01

Last updated by the study team

2011-10-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is between 18 and 75 years of age.
• Patient is scheduled for a spinal procedure that entails a dural incision.
• Patient requires a procedure involving surgical wound classification Class I/Clean (per CDC criteria).
• Patient, or authorized representative, has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
• Intraoperative Criteria: Presence of non-watertight closure, either spontaneously or upon Valsalva maneuver to 20-25 cm H20 for 5-10 seconds.

You may not qualify if…

• Patient has active spinal and/or systemic infection.
• Patient will require additional spine surgery within the study time period.
• Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure.
• Patient has pre-existing external lumbar CSF drain or internal CSF shunt.
• Patient is participating in a clinical trial of another investigational device or drug.
• Patient with creatinine > 2.0 mg/dL.
• Patient with total bilirubin > 2.5 mg/dL.
• Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation.
• Patient has been treated with chronic steroid therapy unless discontinued more than 6 weeks prior to surgery (standard perioperative steroids are permitted). For purposes of this protocol, chronic steroid therapy is defined as greater than 4 weeks.
• Patient has documented history of significant coagulopathy with a PTT > 35 sec, PT/ INR >1.2, receiving aspirin, or NSAIDS at the time of surgery. Note: Patients who are receiving cardiovascular prophylaxis are not excluded.
• Patient is receiving warfarin or heparin at the time of surgery (including analogs).
• Patient has a diagnosed and documented compromised immune system and/or autoimmune disease.
• Patient has had chemotherapy treatment within 6 months prior to, or planned during the study (until completion of last follow-up evaluation).
• Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure.
• Patient has a known malignancy or another condition with prognosis shorter than 6 months.
• Patients has a documented history of uncontrolled diabetes.
• The investigator determines that the patient should not be included in the study for reason(s) not already specified.
• Intraoperative Criteria: Patient requires use of a synthetic or non-autologous duraplasty material.
• Intraoperative Criteria: Patient has a gap of greater than 2mm remaining after primary dural closure.
• Patient has undergone laminoplasty decompression.
• Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level.
• Investigator determines that participation in the study may jeopardize the safety or welfare of the patient.
• Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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