Trial Outcomes & Findings for Duragen® Secure Post Marketing Clinical Follow-up (PMCF) (NCT NCT02225080)
NCT ID: NCT02225080
Last Updated: 2018-10-09
Results Overview
Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
Day 30
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Duragen Secure
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Duragen Secure
n=100 Participants
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 14.76 • n=100 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Day 30Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
Outcome measures
| Measure |
Duragen Secure
n=100 Participants
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Patient's Outcome
Recovered without sequelae
|
73 Participants
|
|
Patient's Outcome
Ongoing with medical intervention
|
7 Participants
|
|
Patient's Outcome
Ongoing with surgical intervention
|
15 Participants
|
|
Patient's Outcome
Deceased
|
3 Participants
|
|
Patient's Outcome
Other
|
2 Participants
|
SECONDARY outcome
Timeframe: first 72 hours post-opAdverse event that occured 72 hours post-operatively
Outcome measures
| Measure |
Duragen Secure
n=100 Participants
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Occurence of Adverse Event
|
19 Participants
|
SECONDARY outcome
Timeframe: between days 4-14Adverse event that occured between days 4-14 post-operatively
Outcome measures
| Measure |
Duragen Secure
n=100 Participants
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Occurence of Adverse Event
|
18 Participants
|
SECONDARY outcome
Timeframe: Between days 15-30Adverse event that occured between days 15-30 post-operatively
Outcome measures
| Measure |
Duragen Secure
n=100 Participants
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Occurence of Adverse Event
|
15 Participants
|
Adverse Events
Duragen Secure
Serious events: 31 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Duragen Secure
n=100 participants at risk
Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Cardiac disorders
Cardiac arrhythmia
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Gastrointestinal disorders
Dysphagia
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
General disorders
Inflammatory reaction
|
3.0%
3/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
General disorders
Wound healing disturbance
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
General disorders
Death
|
2.0%
2/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
General disorders
Weakness worsened
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Infection
|
4.0%
4/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Meningitis
|
5.0%
5/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
subdural empyema
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Shunt infection
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
cerebral empyema
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Septic shock
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Bronchopneumonia
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Bladder infection
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Infections and infestations
Wound Infection
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Injury, poisoning and procedural complications
Postoperative bleeding
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Injury, poisoning and procedural complications
Graft failure
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Investigations
Cardiac enzymes increased
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm recurrence
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
CSF leakage
|
2.0%
2/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Haematoma cerebral
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Intracranial haemorrhage
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Seizure
|
4.0%
4/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Subdural Hygroma
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Hydrocephalus
|
3.0%
3/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Paraparesis
|
2.0%
2/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Hemiparesis
|
2.0%
2/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Hemorrhage intracranial
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Intracranial hypertension
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Dysarthria
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
3.0%
3/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Psychiatric disorders
Organic brain syndrome
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Renal and urinary disorders
Renal insufficiency
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
2/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Surgical and medical procedures
Brain tumor operation
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Vascular disorders
Thrombosis venous deep
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
|
Vascular disorders
Haemorrhage
|
1.0%
1/100 • Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
|
Other adverse events
Adverse event data not reported
Additional Information
Director, Global Clinical Affairs
Integra LifeSciences Corporation
Phone: 609-936-5490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60