NCT00859508CompletedNot Applicable
A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery
Synthes USA HQ, Inc.16 sites in 1 country99 target enrollmentStarted: February 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 99
- Locations
- 16
- Primary Endpoint
- Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Wound Healing Assessment(up to 6 months)
- Radiographic Evaluation(6 months)
- Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)(up to 6 months)
- Modified Rankin Scale (Patient Function Assessment)(up to 6 months)
- Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)(up to 6 months)
Investigators
Study Sites (16)
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