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Study of SyntheCelTM Dura Replacement to Other Dura Replacements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00859508
First received: March 6, 2009
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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 Intervention
Cranial Dura Repair
Device: SyntheCel
Device: Other FDA cleared dura replacements

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Modified Rankin Scale (Patient Function Assessment) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.) [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Wound Healing Assessment [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Radiographic Evaluation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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


Enrollment: 99
Study Start Date: February 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859508

Locations
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.
  More Information

Publications:
Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00859508     History of Changes
Obsolete Identifiers: NCT00454844
Other Study ID Numbers: SyntheCel
Study First Received: March 6, 2009
Results First Received: February 3, 2012
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014