Study of SyntheCelTM Dura Replacement to Other Dura Replacements

• ClinicalTrials.gov Identifier: NCT00859508
• Recruitment Status: Completed
• First Posted: March 11, 2009
• Results First Posted: March 6, 2012
• Last Update Posted: March 8, 2012
• Sponsor: Synthes USA HQ, Inc.
• Information provided by (Responsible Party): Synthes USA HQ, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cranial Dura Repair	Device: SyntheCel; Device: Other FDA cleared dura replacements	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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 Start Date: February 2006
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: SyntheCel	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.
Active Comparator: other FDA cleared dura replacements	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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Modified Rankin Scale (Patient Function Assessment) [ Time Frame: up to 6 months ]
2. Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.) [ Time Frame: up to 6 months ]
3. Wound Healing Assessment [ Time Frame: up to 6 months ]
4. Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality) [ Time Frame: up to 6 months ]
5. Radiographic Evaluation [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arizona

Barrow Neurosurgical Institute

Scottsdale, Arizona, United States, 85251

United States, California

Stanford Medical Center

Stanford, California, United States, 94305

United States, Florida

University of Florida

Gainesville, Florida, United States, 32611

United States, Oregon

Oregon Health Sciences University

Portland, Oregon, United States, 97239

United States, Pennsylvania

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

United States, Texas

University of Texas

Houston, Texas, United States, 77030

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

United States, West Virginia

West Virginia University School of Medicine

Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Synthes USA HQ, Inc.

More Information

Publications of Results:

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.

• Responsible Party: Synthes USA HQ, Inc.
• ClinicalTrials.gov Identifier: NCT00859508
• Obsolete Identifiers: NCT00454844
• Other Study ID Numbers: SyntheCel
• First Posted: March 11, 2009
• Results First Posted: March 6, 2012
• Last Update Posted: March 8, 2012
• Last Verified: March 2012

Keywords provided by Synthes USA HQ, Inc.:

dura repair following cranial surgery

Additional relevant MeSH terms:

Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female