Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures

February 26, 2014 updated by: HyperBranch Medical Technology, Inc

A Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures

The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After surgery on the head, the dura, a membrane that covers the brain, must be closed in order to prevent CSF from leaking outside of the dura. When CSF leaks outside the dura, this can increase the risk of infection, cause painful headaches or complications that may require another surgery to repair the leak. Typically, your study doctor will close the dura with sutures (surgical stitches) and sometimes a piece of muscle, fat, or other soft tissue taken from another place on your body. However, it is still possible that CSF will continue to leak through small suture holes even when all appropriate precautions have been taken.

Dural surgical sealants have been developed to assist surgeons in stopping CSF leaks when standard measures following brain surgery are not effective. Sometimes, the leak seals on its own and there is no need for a surgical sealant.

This study is for participants who have a CSF leak after standard measures are used to close the dura at the end of their surgery. The decision to use a surgical sealant will be made when your surgeon finds that after stitching and using standard measures to close the dura, there is still a leak.

However, if your surgeon finds a CSF leak after he or she applies the standard stitches and tissues, and you have signed this informed consent, then you will be randomized to receive one of two surgical sealants (Randomized means like a flip of the coin). You will be selected to receive either Adherus™ Surgical Sealant or DuraSeal™ Surgical Sealant and your post surgery progress will be evaluated during study visits and with study tests. Adherus™ Surgical Sealant is an investigational device that has been developed to stop CSF leaks. It is being studied to find if it is just as effective and safe as DuraSeal™.

Adherus™ is made of two components that form a gel when they are combined. The gel is applied after the study doctor closes the incision. The gel acts as a thin, elastic barrier intended to prevent CSF from leaking until the dura tissue has properly healed on its own. The gel is then absorbed by the body over several months and excreted or removed from the body through the urine. This is the second study of Adherus™ in people in the United States.

If you choose to participate, you will have screening tests to see if you qualify to enroll in the study. Not everyone who is screened for the study will be able to participate. The device you receive will be determined by a random selection process. Neither you nor study personnel or your doctor can decide which device you receive. You will not be told which device you received until study completion. In addition, if your study doctor does not use any sealant at the end of your surgery (you may not have any CSF leak or the study doctor decides to use another closure procedure) then your study participation will be complete.

If you choose to participate and have screening tests to qualify you to enroll in the study, your surgery will be performed according to the regular standard of care. If CSF leaks from your dura after it is stitched closed by your study doctor and you continue to meet study entry measures, then your study doctor will apply the assigned study treatment to try to stop the leak. After the surgery, you will be seen 4 times over the next 4 months. You will be in the study for up to 5 months.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Colorado Brain and Spine Institute/Swedish Medical Center
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Saint Louis University
    • New York
      • Stony Brook, New York, United States, 11794-8122
        • Stony Brook University Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina NeuroSurgery & Spine Associates
      • Winston-Salem, North Carolina, United States, 27157-1029
        • Wake Forest School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Mayfield Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74132
        • Oklahoma Spine and Brain Institute
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State University Milton S. Hershey Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9183
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pre-Operative Inclusion Criteria
  • Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered)

Intra-Operative Inclusion Criteria

  • Subject's linear extent of durotomy is ≥2 cm
  • Subject's dural margins from the edges of bony defect are ≥3 mm throughout
  • Subject's CSF leak is present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds

Exclusion Criteria:

  • Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells are appropriately sealed (e.g. bone wax).
  • Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts.
  • Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery.
  • Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an exclusion criterion).
  • Subject has a systemic infection or evidence of any infection near planned operative site.

Intra-Operative Exclusion Criteria

  • Subject has an Incidental finding that meets any pre-operative exclusion criterion listed above.
  • Subject requires the intra-operative placement of a CSF diversion device (e.g. ventricular catheter, subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that will be left in place after the procedure. Note: Subgaleal drains used for acute post-operative management of the incision site are permitted.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DuraSeal Dural Sealant System
Device: Adherus Dural Sealant
In situ polymerizing sealant
Experimental: Adherus Dural Sealant System
Device: Adherus Dural Sealant
In situ polymerizing sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site
Time Frame: 120 days

The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:

  • Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.
  • CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure
  • Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period.
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.
Time Frame: 120 days
Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HyperBranch Medical Technology, Inc

Investigators

  • Principal Investigator: Mark Smith, MD, Carolina NeuroSurgery & Spine Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBMT-080453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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