Study of SyntheCelTM Dura Replacement to Other Dura Replacements

Not Applicable

Completed

• Conditions: Cranial Dura Repair
• Interventions: Device: Other FDA cleared dura replacements; Device: SyntheCel

• Registration Number: NCT00859508
• Lead Sponsor: Synthes USA HQ, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Disposition First Submitted: 2010-08-27
• Disposition First Submitted QC: 2012-01-23
• Disposition First Posted: 2012-01-27
• Results First Submitted: 2012-02-03
• Results First Submitted QC: 2012-02-03
• Status Verified: 2012-03
• Results First Posted: 2012-03-06
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
other FDA cleared dura replacements	Other FDA cleared dura replacements	-
SyntheCel	SyntheCel	-

Primary Outcome Measures

Name	Time	Method
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele	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 Outcome Measures

Name	Time	Method
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	6 months	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
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

Trial Locations

Locations (8)

Barrow Neurosurgical Institute; 🇺🇸 Scottsdale, Arizona, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Stanford Medical Center; 🇺🇸 Stanford, California, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas; 🇺🇸 Houston, Texas, United States

West Virginia University School of Medicine; 🇺🇸 Morgantown, West Virginia, United States