Dura Mater Nick Cut or Tear, Surgery
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Outcome | Day 30 | Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Adverse Event | first 72 hours post-op | Adverse event that occured 72 hours post-operatively |
Countries
France, Germany, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duragen Secure Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Duragen Secure | — |
|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 14.76 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 57 Participants | — |
| Sex: Female, Male Male | 43 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 31 / 100 |
Outcome results
Primary
Patient's Outcome
Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
Time frame: Day 30
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Duragen Secure | Patient's Outcome | Recovered without sequelae | 73 Participants |
| Duragen Secure | Patient's Outcome | Ongoing with medical intervention | 7 Participants |
| Duragen Secure | Patient's Outcome | Ongoing with surgical intervention | 15 Participants |
| Duragen Secure | Patient's Outcome | Deceased | 3 Participants |
| Duragen Secure | Patient's Outcome | Other | 2 Participants |
Secondary
Occurence of Adverse Event
Adverse event that occured 72 hours post-operatively
Time frame: first 72 hours post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duragen Secure | Occurence of Adverse Event | 19 Participants |
Secondary
Occurence of Adverse Event
Adverse event that occured between days 4-14 post-operatively
Time frame: between days 4-14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duragen Secure | Occurence of Adverse Event | 18 Participants |
Secondary
Occurence of Adverse Event
Adverse event that occured between days 15-30 post-operatively
Time frame: Between days 15-30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duragen Secure | Occurence of Adverse Event | 15 Participants |