Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxter Healthcare Corporation
Age
3–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects undergoing elective craniotomy / craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformations, and Chiari 1 malformations) that result in dura defects requiring dura substitution for closure and who are able and willing to comply with the procedures required by the protocol
Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures
Age \>= 3 years, either gender
Surgical Wound Classification Class I and Risk Index Category (RIC) \<= 2. Penetration of mastoid air cells during partial mastoidectomy is permitted and will be recorded.
A patch of autologous fascia or pericranium or suturable collagen-based dura substitute was cut to size and then sutured into the dura defect.
The hem of native dura exposed along and under the craniotomy edge is wide enough to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
You may not be if
Female subjects who are breastfeeding, pregnant, or intend to become pregnant during the clinical study period
Subjects with a dura lesion from a recent surgery that still has the potential for cerebrospinal fluid (CSF) leakage unless it can be expected that the lesion will be excised completely, including all old suture holes
Chemotherapy scheduled within 7 days following surgery
Radiation therapy to the head scheduled within 7 days following surgery
Subjects with severely altered renal (serum creatinine \> 2 mg/dL) and/or hepatic function \[ALT, AST \> 5 x upper limit of norm (ULN)\]
Evidence of an infection indicated by any one of the following: fever \> 101°F, white blood cell (WBC) count \< 3500/μL or \> 13000/μL, positive blood culture, positive chest X-ray. A positive urine culture (\> 10\^5 colony-forming units (CFU)/mL) leads to exclusion unless acute cystitis is the sole cause. Evidence of infection along the planned surgical path. A WBC count of \< 20000/μL is permitted if the patient is being treated with steroids in the absence of all the other infection parameters.
Conditions compromising the immune system; existence of autoimmune disease
Known hypersensitivity to aprotinin or other components of the investigational product
Non-compliant or insufficient treatment of diabetes mellitus \[glycosylated hemoglobin (HbA1c) \> 7.5%\]
Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology to be treated
Existing CSF (ventricular, etc.) drains. Burr holes are permitted as long as the dura remains intact. Cushing cannulation excludes the subject.
Female subjects of childbearing potential with a positive urine or serum pregnancy test within 24 hours prior to surgery
Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment
Scheduled or foreseeable surgery within the follow-up period
Dura injury during craniotomy / craniectomy that cannot be eliminated by recreating a sufficiently wide native dura hem
Failure to administer preoperative antibiotic prophylaxis
Use of implants made of synthetic materials coming into direct contact with dura (e.g., polytetrafluoroethylene (PTFE) patches, shunts, ventricular and subdural drains)
Placement of Gliadel wafers
Chiari 1 subjects without injury to the arachnoid
Persistent signs of increased brain turgor
Use of product(s) other than FS VH S/D 500 s-apr for the sealing of dura sutures, including packing with Gelfoam
Brain surface visible between suture loops as a manifestation of increased suture tension
CSF leakage from completed dura sutures presenting as dripping drops, growing beads or running trickles. Slight oozing is consistent with successful dura repair and will not lead to exclusion.
Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection
Dura lesion from a recent surgery that cannot be completely excised, including all old suture holes
Two or more separate dura defects
Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
Clareo Health | Fibrin Sealant for the Sealing of Dura Sutures
