SyntheCel Dura Replacement in Patients Requiring Dura Repair - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Synthes Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00454844

Purpose

The objective of the clinical investigation is to demonstrate that the SyntheCelTM Dura Replacement is substantially equivalent to other dura replacements cleared for marketing by the FDA in terms of safety (incidence of surgical site infections) and effectiveness (absence from CSF leaks) for the treatment of dural repair following cranial surgery.

Condition	Intervention	Phase
Brain Disease	Device: SyntheCel Dura Replacement Other: Standard Device	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multi-Center, Controlled Clinical Study Comparing SyntheCel Dura Replacement to Other Dura Replacement in Patients Requiring Dura Repair Following Cranial Surgery

Resource links provided by NLM:

MedlinePlus related topics: Brain Diseases Surgery

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

The goal of this clinical research study is to compare the SyntheCelTM Dura Replacement device to other dura replacement devices in patients requiring dura repair following cranial surgery. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Researchers will compare the effectiveness (how well it works), ability to customize and implant (the ease of use), and the safety of these devices. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	99
Study Start Date:	January 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator SyntheCel Dura Replacement	Device: SyntheCel Dura Replacement Patients will receive the SyntheCel Dura Replacement during surgery.
2 Standard Device	Other: Standard Device Patients will receive the standard device during surgery.

Detailed Description:

SyntheCelTM Dura Replacement devices are made from cellulose fibers that are produced by a specific strain of microorganism. The cellulose fibers are formed into sheets used for SyntheCelTM. The dura is the lining of the brain that needs to be cut in order to get to the tumor during brain tumor surgery. SyntheCelTM is a replacement of the dura when it is cut . The SyntheCelTM Dura Replacement device is not made from human or animal tissues, which lowers the concern regarding disease transmissions that are possible with routine dura replacement devices.

Use of the SyntheCelTM Dura Replacement device may also get rid of the need for using material/tissue from another part of your body as dura replacement. This would get rid of the need for additional surgeries.

Before you can be a part of this study, your surgeon will need to determine if you are a surgical candidate. You will have a complete physical exam and your medical history will be recorded. You will have a neurological exam to see whether the tumor is causing any problems with brain functions. You will have a magnetic resonance imaging (MRI) scan. You will also have routine blood tests (about 2-3 tablespoons). Women who are able to have children must have a negative urine pregnancy test.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either the SyntheCelTM Dura Replacement device or a standard device. Two (2) out of every 3 participants in this study will receive the SyntheCelTM Dura Replacement device. Your surgeon will explain the difference between the SyntheCelTM Dura Replacement device and the other device (s) that your surgeon would normally use for this procedure. You will not find out whether you received the SyntheCelTM Dura Replacement or the alternative treatment device until after the surgery has been performed.

At 10 days after routine surgery or when you leave the hospital, which ever comes first, and at about 30 days, 3 months, and 6 months after your surgery, you will once again have a complete physical exam, and your medical history will be recorded. Your wound will also be evaluated at these times to ensure that you are healing properly. An MRI will be repeated at about 6 months after your surgery. Your participation in this study will be complete at 6 months after surgery.

This is an investigational study. SyntheCelTM Dura Replacement has been approved for use in this study by the FDA as an investigational device for dura replacement in patients having cranial surgery. About 99 patients will take part in this multicenter study. About 25 will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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:

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. 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 PTT greater than or equal to 35, INR greater than or equal to 1.4 or is receiving Warfarin or Coumadin.
Patient has a compromised immune system or autoimmune disease (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454844

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Synthes Inc.

Investigators

Principal Investigator:

Franco DeMonte, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Franco DeMonte, MD/Professor )
Study ID Numbers:	2005-0662
Study First Received:	March 29, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00454844 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

SyntheCel Dura Replacement
Cranial Surgery
Dura Repair

Study placed in the following topic categories:

Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 10, 2009