Use of Spinal Sealant System During Spinal Surgery

This study has been completed.
Sponsor:
Collaborator:
Confluent Surgical
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00458354
First received: March 29, 2007
Last updated: October 10, 2011
Last verified: October 2011
  Purpose
  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.

Condition Intervention Phase
Spine Surgery
Excessive Repair
Spinal Cord Injuries
Complication of Surgical Procedure
Device: Spinal Sealant
Procedure: Standard Methods of Closing of the Dura
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Percent (%) success obtaining watertight closure following assigned treatment (Spinal Sealant or control) [ Time Frame: Determination in course of surgery with up to 90 day post operative follow-up. ] [ Designated as safety issue: No ]
    Percentage (%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or control) defined as either Success (A watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds); or Failure (A non-watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds). This will be determined intraoperatively.


Enrollment: 3
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal Sealant
Dural repair with the Spinal Sealant System.
Device: Spinal Sealant
Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.
Active Comparator: Standard Methods
Dural repair with standard methods such as the closing of the dura with stitches.
Procedure: Standard Methods of Closing of the Dura
Standard methods such as the closing of the dura with stitches.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is between 18 and 75 years of age.
  2. Patient is scheduled for a spinal procedure that entails a dural incision.
  3. Patient requires a procedure involving surgical wound classification Class I/Clean (per CDC criteria).
  4. 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.
  5. Intraoperative Criteria: Presence of non-watertight closure, either spontaneously or upon Valsalva maneuver to 20-25 cm H20 for 5-10 seconds.

Exclusion Criteria:

  1. Patient has active spinal and/or systemic infection.
  2. Patient will require additional spine surgery within the study time period.
  3. Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure.
  4. Patient has pre-existing external lumbar CSF drain or internal CSF shunt.
  5. Patient is participating in a clinical trial of another investigational device or drug.
  6. Patient with creatinine > 2.0 mg/dL.
  7. Patient with total bilirubin > 2.5 mg/dL.
  8. Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation.
  9. 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.
  10. 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.
  11. Patient is receiving warfarin or heparin at the time of surgery (including analogs).
  12. Patient has a diagnosed and documented compromised immune system and/or autoimmune disease.
  13. Patient has had chemotherapy treatment within 6 months prior to, or planned during the study (until completion of last follow-up evaluation).
  14. Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure.
  15. Patient has a known malignancy or another condition with prognosis shorter than 6 months.
  16. Patients has a documented history of uncontrolled diabetes.
  17. The investigator determines that the patient should not be included in the study for reason(s) not already specified.
  18. Intraoperative Criteria: Patient requires use of a synthetic or non-autologous duraplasty material.
  19. Intraoperative Criteria: Patient has a gap of greater than 2mm remaining after primary dural closure.
  20. Patient has undergone laminoplasty decompression.
  21. Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level.
  22. Investigator determines that participation in the study may jeopardize the safety or welfare of the patient.
  23. Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458354

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Confluent Surgical
Investigators
Principal Investigator: Ian E. McCutcheon, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00458354     History of Changes
Other Study ID Numbers: 2005-0641
Study First Received: March 29, 2007
Last Updated: October 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Spinal Sealant
Spinal Sealant System
Dural Repair
Spinal Surgery

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014