Study to Evaluate Safety and Effectiveness of Spinal Sealant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:
NCT00594035
First received: January 2, 2008
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention
Spinal Procedure Requiring Dura Incision
Device: Spinal Sealant System
Device: Standard of care

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

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Watertight Dural Closure [ Time Frame: Intra-Operative ] [ Designated as safety issue: No ]
    Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.


Enrollment: 158
Study Start Date: September 2005
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

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

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
  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: NCT00594035

Locations
United States, Massachusetts
Confluent Surgical, Inc.
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Confluent Surgical
Investigators
Study Director: Vladimir Scerbin Covidien
  More Information

No publications provided

Responsible Party: Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier: NCT00594035     History of Changes
Other Study ID Numbers: DRS-05-001
Study First Received: January 2, 2008
Results First Received: October 30, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
Spinal procedure
Dura incision

ClinicalTrials.gov processed this record on August 20, 2014