Post-market Assessment of Biodesign Dural Repair Grafts

Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts

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 Overview

• Status: Completed
• Conditions: Cerebrospinal Fluid Leak
• Intervention / Treatment: Device: Biodesign Dural or Duraplasty Repair Grafts

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
• Italy
  • Bologna, Italy, 40139
    • Ospedale Bellaria-Bolonga
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Birmingham Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 months

Collaborators and Investigators

• Sponsor: Cook Research Incorporated

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2019
• Primary Completion (ACTUAL): June 6, 2022
• Study Completion (ACTUAL): September 15, 2022

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: CSF leak; dura mater repair; cerebrospinal fluid leak; Biodesign® Dural Repair Graft; Biodesign® Duraplasty Repair Graft
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cerebrospinal Fluid Leak
• Other Study ID Numbers: 17-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes