Post-market Assessment of Biodesign Dural Repair Grafts

Cook Research Incorporated128 enrolled

Overview

The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Cerebrospinal Fluid Leak

Interventions

Biodesign Dural or Duraplasty Repair GraftsDEVICE

Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Planned use of the Biodesign Dural or Duraplasty Graft. Exclusion Criteria: 1. Age \<18 years 2. Unable or unwilling to provide informed consent 3. Life expectancy \<6 months

Locations (3)

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Toronto Western Hospital

Toronto, Ontario, Canada

Ospedale Bellaria-Bolonga

Bologna, Italy

Outcomes

Primary Outcomes

Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage

Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).

Time frame: 2 months

Data from ClinicalTrials.gov

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