Craniotomy
Conditions
Brief summary
The purpose of this study is to assess how safe synthecel dura repair is and how well it performs in participants undergoing cranial surgery requiring dura repair (a procedure to close and protect the outer covering of the brain) in a regular, everyday healthcare environment.
Interventions
None listed
Sponsors
DePuy Synthes Products, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant or legally authorized representative who is willing to participate in the registry and provide written informed consent * Participant undergoing SYNTHECEL implantation for cranial dura repair on or after the start date of the registry study
Exclusion criteria
\- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 3 years and 3 months | Adverse event is any untoward medical occurrence (sign, symptom, or disease) in a subject that is deemed at least possibly related to use of SYNTHECEL, and or the procedure. |
| Demographics Characteristic Of Participants: Age | At baseline | Participant's age at time of surgery will be reported. |
| Demographics Characteristic Of Participants: Sex | At baseline | Participant's sex will be reported. |
| Demographics Characteristic Of Participants: Race | At baseline | Participant's race will be reported. |
| Demographics Characteristic Of Participants: Ethnicity | At baseline | Participant's ethnicity will be reported. |
| Demographics Characteristic Of Participants: Height | At baseline | Participant's height will be reported. |
| Demographics Characteristic Of Participants: Weight | At baseline | Participant's weight will be reported. |
| Demographics Characteristic Of Participants: Body Mass Index (BMI) | At baseline | Participant's BMI will be reported. |
| Demographics Characteristic Of Participants: Targeted Medical And Surgical History | At baseline | Participant's targeted medical and surgical history will be reported. |
| Demographics Characteristic Of Participants: Diagnosis/Indication | At baseline | Participants primary diagnosis/indication for surgery will be reported. |
| Baseline Neurological Assessment | At baseline | Participant's neurological assessment (function) will be reported. Neurological assessment will be reported in a qualitative manner and all assessments will be collected and reported by the hospital site based on the standard clinical practice for the respective institution. Presence of abnormal neurological findings (Yes/No) as determined by neurological assessment will be recorded. |
| Baseline imaging assessment | At baseline | Participant's imaging assessment (MRI or CT scan) will be reported. |
| Date of Procedure | Intraoperative | Date of procedure will be reported. |
| Size of Dura Defect | Intraoperative | Size of dura defect will be reported. |
| Surgical Approach | Intraoperative | Surgical approach used will be reported. |
| Procedure Time | Intraoperative | Procedure time is defined as first incision to final closure. |
| Amount of Blood Loss | Intraoperative | Amount of blood loss during craniotomy or craniectomy procedure will be reported. |
| Device Details | Intraoperative | Device information will be reported. |
| Device Location | Intraoperative | Device location will be reported. |
| Cerebrospinal Fluid (CSF),Drainage Device Use | Intraoperative | Use of CSF drainage device will be reported. |
| Dural Adhesive or Dural Sealant Use | Intraoperative | Use of dural adhesive or dural sealant will be reported. |
| Neurological Status at Discharge | At discharge (within 1 to 14 days following the index procedure) | Neurological status at the time of discharge will be reported. Neurological assessment will be reported in a qualitative manner and all assessments will be collected and reported by the hospital site based on the standard clinical practice for the respective institution. Presence of abnormal neurological findings (Yes/No) as determined by neurological assessment will be recorded. |
| Imaging Assessment at Discharge | At discharge (within 1 to 14 days following the index procedure) | Imaging assessment (MRI or CT scan) will be reported at the time of discharge. |
| Overall Length of Hospital Stay | At discharge (within 1 to 14 days following the index procedure) | Participant's overall length of hospital stay will be reported. |
| Number of Days Since Craniectomy | At discharge (within 1 to 14 days following the index procedure) | Number of Days since craniectomy will be reported. |
| Cranioplasty Operative Time | At discharge (within 1 to 14 days following the index procedure) | Cranioplasty operative time will be reported. |
| Length of Hospital Stay | At discharge (within 1 to 14 days following the index procedure) | Length of hospital stay will be reported. |
| Type of Cranioplasty Implant | Intraoperative | Type of cranioplasty implant used in surgery will be reported. |
| Adhesion Formation | Intraoperative | Adhesion formation at dura repair site will be reported. |
| Membrane formation | Intraoperative | Membrane formation at dura repair site will be reported. |
| Abnormal Thickening | Intraoperative | Abnormal thickening at the SYNTHECEL implant site will be reported. |
| Brain Edema | Intraoperative | Brain edema adjacent to SYNTHECEL site will be reported. |
| CSF Leakage | Intraoperative | CSF leakage at dura repair site will be reported. |
| Pseudomeningocele | Intraoperative | Pseudomeningocele at dura repair site will be reported. |
| Discontinuation Status | Up to 24 months post-index procedure | Participant's discontinuation status will be reported. |
Contacts
CONTACTMaggie Farhat
STUDY_DIRECTORDePuy Synthes Product, Inc. Clinical Trial
DePuy Synthes Product, Inc.
Outcome results
None listed