Study of SyntheCelTM Dura Replacement to Other Dura Replacements

• 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

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.

• 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.
• 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

• Experimental: SyntheCel
  Intervention: Device: SyntheCel
• Active Comparator: other FDA cleared dura replacements
  Intervention: Device: Other FDA cleared dura replacements

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