Assessment of the Performance of LYoplant® ONlay for Duraplasty

Aesculap AG61 enrolled

Overview

The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Craniotomy Duraplasty Spinal Surgery

Interventions

Lyoplant OnlayDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing an elective cranial or spinal surgery, probably with the need of a duraplasty using Lyoplant® Onlay * Written informed consent * Life expectancy \> 6 months * Age \> 18 years Exclusion Criteria: * Active local or systemic infections * Open cranial trauma * Open spina bifida * Known hypersensitivity to proteins of bovine origin * Representation by a legal guardian or under involuntary commitment * Pregnancy * Participation in another clinical study * Known primary immunodeficiency

Locations (3)

Klinikum Darmstadt

Darmstadt, Germany

Klinik für Neurochirurgie

Homburg/Saar, Germany

Klinikum Idar-Oberstein

Idar-Oberstein, Germany

Outcomes

Primary Outcomes

Incidence of re-operation because of Cerebrospinal Fluid leakage

Time frame: until discharge (approximately 1 week)

Secondary Outcomes

Incidence of re-operation because of Cerebrospinal Fluid leakage

Time frame: until follow-up (4 ± 2 months)

Incidence of post operative complications

Cerebrospinal Fluid leakage, pseudomeningocele, fistulae, infection, meningitis and others

Time frame: until discharge (approximately 1 week, 4±2 months)

Incidence of cerebral reactions edema, soft tissue swelling, Cerebrospinal Fluid leakage

detected during routine post operative MRI / CT examinations

Time frame: until discharge (approximately 1 week, 4±2 months)

Intraoperative handling of the device

Intraoperative handling of the device using a questionnaire containing different dimension and a 5 point (1 = excellent, 5 = unacceptable) assessment level (Likert Scale). The following dimensions are assessed: * Ease of cutting * Needle penetration * Adaptation to the tissue * Suture retention strength * Onlay effect * Quality of sealing * Thickness * Tensile strength * Overall satisfaction

Time frame: Intraoperative

Data from ClinicalTrials.gov

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