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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HyperBranch Medical Technology, Inc
ClinicalTrials.gov Identifier:
NCT01158378
First received: July 6, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Elective Cranial Procedures With Dural Incision
Device: Adherus Dural Sealant
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 Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures

Further study details as provided by HyperBranch Medical Technology, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up. [ Time Frame: 120 days ] [ Designated as safety issue: Yes ]
    Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.


Enrollment: 250
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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.
  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: NCT01158378

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

Publications:
Responsible Party: HyperBranch Medical Technology, Inc
ClinicalTrials.gov Identifier: NCT01158378     History of Changes
Other Study ID Numbers: HBMT-080453
Study First Received: July 6, 2010
Results First Received: February 26, 2014
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by HyperBranch Medical Technology, Inc:
Adherus Dural Sealant
Adherus AutoSpray Dural Sealant

ClinicalTrials.gov processed this record on October 19, 2014