Study to Evaluate Safety and Effectiveness of Spinal Sealant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594035
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : December 3, 2009
Last Update Posted : September 7, 2017
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Procedure Requiring Dura Incision Device: Spinal Sealant System Device: Standard of care Not Applicable

Detailed Description:
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1
Spinal Sealant
Device: Spinal Sealant System
Active Comparator: 2
Standard of care
Device: Standard of care
Standard of care: devices intended to provide a watertight closure
Other Name: (i.e. devices intended to provide a watertight closure)

Primary Outcome Measures :
  1. Watertight Dural Closure [ Time Frame: Intra-Operative ]
    Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation.
  • Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria)
  • Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.

Exclusion Criteria:

  • Active spinal and/or systemic infection
  • Patient requires additional spinal 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 a 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 (>4 weeks) unless discontinued more than 6 weeks prior to surgery
  • Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery
  • Patient receiving warfarin or heparin at the time of surgery
  • Patient has a diagnosed and documented compromised immune system and/or autoimmune disease
  • Patient has has chemotherapy treatment within 6 months prior to, or planned during the study
  • Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure
  • Patient has known malignancy or other condition with prognosis shorter than 6 months
  • Patients with documented history of uncontrolled diabetes
  • Patient requires use of synthetic or non-autologous duraplasty material
  • Patient has a gap greater than 2mm remaining after primary dural closure
  • Patient has undergone laminoplasty decompression
  • Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position
  • Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level
  • The investigator determines that participation in the study may jeopardize the safety or welfare of the patient
  • The investigator determines that the patient should not be included in the study for reason(s) not already specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594035

United States, Massachusetts
Confluent Surgical, Inc.
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Integra LifeSciences Corporation
Study Director: Vladimir Scerbin Medtronic - MITG

Responsible Party: Integra LifeSciences Corporation Identifier: NCT00594035     History of Changes
Other Study ID Numbers: DRS-05-001
First Posted: January 15, 2008    Key Record Dates
Results First Posted: December 3, 2009
Last Update Posted: September 7, 2017
Last Verified: August 2017

Keywords provided by Integra LifeSciences Corporation:
Spinal procedure
Dura incision

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries