DuraSIS^TM Dural Substitute Study

 Joseph Maroon, MD

Introduction:

This study is a follow-up study to the clinical safety evaluation of Durasis™ dura substitute already successfully completed at Presbyterian University Hospital by the current group of Investigators. This first study, on 5 patients requiring a dura patch following brain surgery, demonstrated the following characteristics of Durasis™.  Freedom from:

• Device failure
• CSF leak
• Infection
• Other surgical or post-surgical complications

Study Design

This FDA directed study designed by Cook, Inc, West Lafayette, IN, is designed to assess the procedural success and safety of using Durasis in approximately 90 patients at 6 clinical sites. The Durasis™ Dural Substitute success is based on its ability to seal the dural defect and there is no CSF leak at the device site at the end of the surgical procedure. Our Investigators except to enroll 10 to 20 patients. This product results will be compared to already existing natural and artificial dura substitutes.

Other Assessments:

• Karnofsky Performance Status (KPS)
• Infection
• Meningitis/Inflammation
• Any other complications
• Histopathology (when available)

Patient Inclusion Criteria

• 1. Cranial or spinal dural defect requiring placement of a graft or substitute;
• 2. Age greater than or equal to 21 years;
• 3. Life expectancy greater than six (6)months; and
• 4. Signed informed consent.

Patient Exclusion Criteria

• 1. Prior non-autologous dural substitute;
• 2. Allergy to porcine derived products;
• 3. Systemic collagen disease;
• 4. Chronic usage of immuno-suppressive agents;
• 5. Infection;
• 6. Glioblastoma multiforma;
• 7. Astrocytoma (grade 4);
• 8. Use of radiation therapy to the site;
• 9. Objections to the use of blood or porcine products; or
• 10. Enrollment in other clinical evaluation.

Follow-up

• Post-Operative to Discharge
• 1, 2, and 4 weeks
• 12 month evaluation

Post-Operative Data

• Document Procedural Success
• Document any post procedure complications
• Document post procedure adverse events
• Perform KPS at time of discharge
• Indicate date of hospital discharge

Follow-Up Exam Data

• Document any follow-up complications
• Document any follow-up adverse events
• Perform and record KPS
• Provide data from cranial imaging, if performed
• Evaluate and document clinical success (Procedural success with no rupture of the Durasis™ Dural Substitute within 30 days of the initial surgical procedure.
• Evaluate and document overall outcome (excellent, good, fair, poor).

Subsequent Intervention

• Describe outcome of any cranial imaging
• Describe reason for intervention
• Describe findings
• If possible, grossly evaluate Durasis™ Dural Substitute
• If possible, obtain tissue samples of Durasis™ Dural Substitute and surrounding dura for histopathology.

Call 1-888-234-4357 for more information.

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Clinical information is provided for educational purposes and not as a medical or professional service. Person(s) who are not medical professionals should have clinical information reviewed and interpreted or applied only by the appropriate health professional(s).

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 © 2006 Tri-State Neurosurgical Associates - UPMC

Last Updated: Mar 12, 2003