Clinical trial NCT00859508: Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cranial Dura Repair
Keywords: dura repair following cranial surgery
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
timeFrame: 6 months
Secondary outcomes:
measure: Modified Rankin Scale (Patient Function Assessment)
timeFrame: up to 6 months
measure: Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
timeFrame: up to 6 months
measure: Wound Healing Assessment
timeFrame: up to 6 months
measure: Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
timeFrame: up to 6 months
measure: Radiographic Evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Barrow Neurosurgical Institute
state: Arizona
city: Stanford
country: United States
facility: Stanford Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University School of Medicine
state: West Virginia
Study officials:
References:
citation: Rosen CL, Steinberg GK, DeMonte F, Delashaw JB Jr, Lewis SB, Shaffrey ME, Aziz K, Hantel J, Marciano FF. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. doi: 10.1227/NEU.0b013e3182284aca.