Study of SyntheCelTM Dura Replacement to Other Dura Replacements

Study Overview
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Brief Summary
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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.

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

Conditions
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Cranial Dura Repair

Intervention / Treatment
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* Device: SyntheCel
* Device: Other FDA cleared dura replacements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SyntheCel<br> | Device: SyntheCel<br>* 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.<br>|
| Active Comparator: other FDA cleared dura replacements<br> | Device: Other FDA cleared dura replacements<br>* 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.<br>* Other names: Durepair Dura regeneration Matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele | 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) |  | up to 6 months | 
| Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.) |  | up to 6 months | 
| Wound Healing Assessment |  | up to 6 months | 
| Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality) |  | up to 6 months | 
| Radiographic Evaluation | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dura repair following cranial surgery