Chiari Malformation, Craniotomy, Dural Fistula, Duraplasty, Hydrocephalus, Meningioma, Spinal Surgery, Tethered Cord, Tumor, Brain, Vascular Malformation
Conditions
Keywords
duraplasty, dural substitute, synthetic graft, Neuro-Patch®
Brief summary
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age \> 18 years * Duraplasty using Neuro-Patch® according to the Instructions for Use
Exclusion criteria
* Use in infected regions * Use in open cerebrocranial traumata * Use in open spina bifida * Known hypersensitivity to implant materials * Pregnancy * Representation by a legal guardian or under involuntary commitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications | until follow-up (up to one year after surgery) | Incidence of complications, with (potential) causal relationship to Neuro-Patch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handling measures | Intraoperative | Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor) |
| Incidence of complications not related to Neuro Patch | until follow-up (up to one year after surgery) | Incidence of complications, without causal relationship to Neuro-Patch |
Countries
France, Germany
Outcome results
None listed