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An Exploratory Phase 2 Study Evaluating the Efficacy and Safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent Treated (FS VH S/D) 500 S-APR for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery

Phase 2
3 Years
Not Enrolling
Pathological Processes in the Posterior Fossa, Dura Defects

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Trial Information

An Exploratory Phase 2 Study Evaluating the Efficacy and Safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent Treated (FS VH S/D) 500 S-APR for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery

Inclusion Criteria:


Inclusion Criteria:

- 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

- 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


Inclusion Criteria:

- Surgical Wound Classification Class I and 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.

Exclusion Criteria:

Preoperative Exclusion Criteria:

- 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
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, WBC <
3500/μL or > 13000/μL, positive blood culture,positive chest X-ray. A positive urine
culture (> 10^5 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 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

- 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

Intraoperative Exclusion Criteria:

- 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., 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of cerebrospinal fluid (CSF) leakage observed within 33 +/- 3 days after surgery in each cohort.

Outcome Time Frame:

33 +/- 3 days after surgery

Safety Issue:


Principal Investigator

Guenter Zuelow, MD

Investigator Role:

Study Director

Investigator Affiliation:

Baxter Healthcare Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

July 2010

Related Keywords:

  • Pathological Processes in the Posterior Fossa
  • Dura Defects
  • Pathologic Processes



City of Hope Medical Center Duarte, California  91010
Northwestern University Chicago, Illinois  60611
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
UC Davis Medical Center, Department of Neurological Surgery Sacramento, California  95817
Rady Children´s Hospital of San Diego San Diego, California  92123
Neurosurgeons for Kids Orlando, Florida  32806
Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University, Department of Neurosurgery Atlanta, Georgia  30322
University of Louisville, Department of Neurological Surgery Louisville, Kentucky  40202
Southern New York NeuroSurgical Group, P.C. Johnson City, New York  13790
Ohio State University Health Sciences Columbus, Ohio  91362