Status:
COMPLETED
Use of Spinal Sealant System During Spinal Surgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Confluent Surgical
Conditions:
Spine Surgery
Excessive Repair
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00458354
Start Date
January 1 2006
End Date
December 1 2008
Last Update
October 12 2011
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030