- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00859508
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
Status
Completed
Conditions
Intervention / Treatment
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
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Arizona
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Scottsdale, Arizona, United States, 85251
- Barrow Neurosurgical Institute
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California
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Stanford, California, United States, 94305
- Stanford Medical Center
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health Sciences University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Texas
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Houston, Texas, United States, 77030
- University of Texas
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University School of Medicine
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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
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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.
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Active Comparator: other FDA cleared dura replacements
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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:
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin Scale (Patient Function Assessment)
Time Frame: up to 6 months
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up to 6 months
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Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
Time Frame: up to 6 months
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up to 6 months
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Wound Healing Assessment
Time Frame: up to 6 months
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up to 6 months
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Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
Time Frame: up to 6 months
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up to 6 months
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Radiographic Evaluation
Time Frame: 6 months
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Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SyntheCel
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.
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