Use of Spinal Sealant System During Spinal Surgery

NCT00458354 | Completed Phase 3 DMC

• 1 other identifier: 2005-0641
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Spine Surgery; Excessive Repair; Spinal Cord Injuries; Complication of Surgical Procedure

Keywords

Spinal Sealant; Spinal Sealant System; Dural Repair; Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• Percent (%) success obtaining watertight closure following assigned treatment (Spinal Sealant or control)

  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.

  Determination in course of surgery with up to 90 day post operative follow-up.

Study Arms (2)

Spinal Sealant

EXPERIMENTAL

Dural repair with the Spinal Sealant System.

Device: Spinal Sealant

Standard Methods

ACTIVE COMPARATOR

Dural repair with standard methods such as the closing of the dura with stitches.

Procedure: Standard Methods of Closing of the Dura

Interventions

Spinal Sealant DEVICE

Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.

Spinal Sealant

Standard Methods of Closing of the Dura PROCEDURE

Standard methods such as the closing of the dura with stitches.

Standard Methods

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Confluent Surgical: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ian E. McCutcheon, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 10, 2007
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)