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

NCT ID: NCT01158378

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-01-31

Brief Summary

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.

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.

Conditions

Elective Cranial Procedures With Dural Incision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DuraSeal Dural Sealant System

Group Type: ACTIVE_COMPARATOR

Adherus Dural Sealant

Intervention Type: DEVICE

In situ polymerizing sealant

Adherus Dural Sealant System

Group Type: EXPERIMENTAL

Adherus Dural Sealant

Intervention Type: DEVICE

In situ polymerizing sealant

Interventions

Adherus Dural Sealant

In situ polymerizing sealant

Intervention Type: DEVICE

Eligibility Criteria

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)

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HyperBranch Medical Technology, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Carolina Neurosurgery & Spine Associates

Locations

Colorado Brain and Spine Institute/Swedish Medical Center

Englewood, Colorado, United States

Florida Hospital

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Wayne State University

Detroit, Michigan, United States

Borgess Research Institute

Kalamazoo, Michigan, United States

Saint Louis University

St Louis, Missouri, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Mayfield Clinic

Cincinnati, Ohio, United States

Oklahoma Spine and Brain Institute

Tulsa, Oklahoma, United States

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

References

Bakar B, Kose EA, Balci M, Atasoy P, Sarkarati B, Alhan A, Kilinc K, Keskil IS. Evaluation of the neurotoxicity of the polyethylene glycol hydrogel dural sealant. Turk Neurosurg. 2013;23(1):16-24. doi: 10.5137/1019-5149.JTN.6039-12.1.

Reference Type: BACKGROUND

PMID: 23344862 (View on PubMed)

Other Identifiers

HBMT-080453

Identifier Type: -

Identifier Source: org_study_id