Study of SyntheCelTM Dura Replacement to Other Dura Replacements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00859508
Recruitment Status : Completed
First Posted : March 11, 2009
Results First Posted : March 6, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
Synthes USA HQ, Inc.

Brief Summary:
Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.

Condition or disease Intervention/treatment Phase
Cranial Dura Repair Device: SyntheCel Device: Other FDA cleared dura replacements Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery
Study Start Date : February 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: SyntheCel Device: SyntheCel
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.

Active Comparator: other FDA cleared dura replacements Device: Other FDA cleared dura replacements
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
Other Names:
  • Duraform Dural Graft Implant
  • Duragen II Dural Regeneration Matrix
  • Duragen Dural Graft Matrix
  • Durepair Dura regeneration Matrix

Primary Outcome Measures :
  1. Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele [ Time Frame: 6 months ]
    The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.

Secondary Outcome Measures :
  1. Modified Rankin Scale (Patient Function Assessment) [ Time Frame: up to 6 months ]
  2. Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.) [ Time Frame: up to 6 months ]
  3. Wound Healing Assessment [ Time Frame: up to 6 months ]
  4. Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality) [ Time Frame: up to 6 months ]
  5. Radiographic Evaluation [ Time Frame: 6 months ]

    Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)

    • Adhesion formation
    • Membrane formation
    • Abnormal thickening along graft (device implant) site
    • Brain edema adjacent to graft (device implant) site

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is between 18 and 75 years of age
  • Patient is scheduled for an elective cranial procedure requiring a dural incision
  • Patient has an MRI no earlier than two months prior to the date of enrollment
  • Surgical wound is expected to be Class I/clean
  • Patient is available and willing to participate in the investigation for the duration of the study
  • Patient has signed a written Informed Consent to participate in the study prior to any study mandated determinations or procedures. This does not include MRIs that may be performed prior to obtaining informed consent.

Exclusion Criteria:

  • Patient has a cranial metallic implant(s) that would interfere with evaluation of the device or recovery
  • Patient is somnolent or comatose (Glasgow score< 8)
  • Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
  • Patient will require use of a dural adhesive or sealant
  • Patient has known hydrocephalus
  • Patient's life expectancy is less than 6 months
  • Patient has a systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 101°F, positive blood culture and/or a positive chest x-ray for acute infectious process
  • Patient has known allergy to device component (cellulose)
  • Patient is an acute cranial trauma surgical case
  • Patient has a local cranial infection
  • Patient has had chemotherapy and/or radiation treatment within 12 weeks prior to surgery, or has chemotherapy and/or radiation treatment planned 10 weeks post surgery
  • Patient has been clinically diagnosed with malignancy (other than basal cell carcinoma or low grade glioma), uncontrolled diabetes, sepsis, systemic collagen disease
  • Patient has creatinine levels > 2.0 mg/dL
  • Patient has total bilirubin level > 2.5 mg/dL
  • Patent has clinically significant coagulopathy with a partial thromboplastin time (PTT) ≥ 35, international normalized ratio (INR) ≥ 1.2, or is receiving Warfarin or Coumadin
  • Patient has a compromised immune system or autoimmune disease (white blood cell (WBC) count <4000/uL or >20,000/uL)
  • Patient is participating in another clinical trial using investigational devices/drugs
  • Patient is pregnant or breastfeeding or wishes to become pregnant during the course of the study
  • Patient is unable or unwilling to sign a consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00859508

United States, Arizona
Barrow Neurosurgical Institute
Scottsdale, Arizona, United States, 85251
United States, California
Stanford Medical Center
Stanford, California, United States, 94305
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
University of Texas
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
United States, West Virginia
West Virginia University School of Medicine
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Synthes USA HQ, Inc.

Publications of Results:
Responsible Party: Synthes USA HQ, Inc. Identifier: NCT00859508     History of Changes
Obsolete Identifiers: NCT00454844
Other Study ID Numbers: SyntheCel
First Posted: March 11, 2009    Key Record Dates
Results First Posted: March 6, 2012
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Synthes USA HQ, Inc.:
dura repair following cranial surgery

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female