Study of SyntheCelTM Dura Replacement to Other Dura Replacements

NCT00859508 | Completed Results

• 1 other identifier: SyntheCel
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 8

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.

Conditions

Cranial Dura Repair

Keywords

dura repair following cranial surgery

Outcome Measures

Primary Outcomes (1)

• Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele

  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.

  6 months

Secondary Outcomes (5)

• Modified Rankin Scale (Patient Function Assessment)

  up to 6 months

• Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)

  up to 6 months

• 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

Study Arms (2)

SyntheCel

EXPERIMENTAL

Device: SyntheCel

other FDA cleared dura replacements

ACTIVE COMPARATOR

Device: Other FDA cleared dura replacements

Interventions

SyntheCel DEVICE

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.

SyntheCel

Other FDA cleared dura replacements DEVICE

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.

Also known as: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, Durepair Dura regeneration Matrix

other FDA cleared dura replacements

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

Study Sites (8)

Barrow Neurosurgical Institute

Scottsdale, Arizona, 85251, United States

Location

Stanford Medical Center

Stanford, California, 94305, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

West Virginia University School of Medicine

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 21670715 RESULT

Results Point of Contact

• Title: Heidi Hausner, Clinical Research Manager
• Organization: Synthes USA HQ, Inc.

hausner.heidi@synthes.com

610-719-5707

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 11, 2009
• Study Start: February 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 8, 2012
• Results First Posted: March 6, 2012

Record last verified: 2012-03

Locations

US (8)