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