Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
|Elective Cranial Procedures With Dural Incision||Device: Adherus Dural Sealant||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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|
- 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.
- 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.
|Study Start Date:||June 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158378
|United States, Colorado|
|Colorado Brain and Spine Institute/Swedish Medical Center|
|Englewood, Colorado, United States, 80113|
|United States, Florida|
|Orlando, Florida, United States, 32804|
|University of South Florida|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|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|
|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|
|Principal Investigator:||Mark Smith, MD||Carolina Neurosurgery & Spine Associates|