Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.

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Key information

Conditions

Dura Mater Nick Cut or Tear Lacerations Surgery Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Lariboisière, Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Exclusion criteria

Patient who does not agree to allow collection of his/her medical data

Treatment and study plan

Primary outcomes

Patient's Outcome

Time frame: Day 30

Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)

Secondary outcomes

Occurence of Adverse Event

Time frame: first 72 hours post-op

Adverse event that occured 72 hours post-operatively
Occurence of Adverse Event

Time frame: between days 4-14

Adverse event that occured between days 4-14 post-operatively
Occurence of Adverse Event

Time frame: Between days 15-30

Adverse event that occured between days 15-30 post-operatively

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Aug 25, 2014
Registry last updated: Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed