Study of SyntheCelTM Dura Replacement to Other Dura Replacements

March 6, 2012 updated by: Synthes USA HQ, Inc.

A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (Patient Function Assessment)
Time Frame: up to 6 months
up to 6 months
Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
Time Frame: up to 6 months
up to 6 months
Wound Healing Assessment
Time Frame: up to 6 months
up to 6 months
Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
Time Frame: up to 6 months
up to 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cranial Dura Repair

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