Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02225080
• Collaborator: (none)
• Enrollment: 100
• Locations: 5
• Duration (Months): 20
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dura Mater Nick Cut or Tear; Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Duragen Secure Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Outcome Measures

Primary Outcome Measures

1. Patient's Outcome [Day 30]

   Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)

Secondary Outcome Measures

1. Occurence of Adverse Event [first 72 hours post-op]

   Adverse event that occured 72 hours post-operatively

2. Occurence of Adverse Event [between days 4-14]

   Adverse event that occured between days 4-14 post-operatively

3. Occurence of Adverse Event [Between days 15-30]

   Adverse event that occured between days 15-30 post-operatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Lariboisière	Paris		France
2	die Charité - Universitätsmedizin Berlin	Berlin		Germany
3	Hospital Universitario 12 de Octubre	Madrid		Spain
4	Hospital Universitario La Fe	Valencia		Spain
5	National Hospital for Neurology and Neurosurgery	London		United Kingdom

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT02225080
• Other Study ID Numbers: N-DURSEC-001
• First Posted: Aug 25, 2014
• Last Update Posted: Oct 9, 2018
• Last Verified: Sep 1, 2018

Study Results

Participant Flow

Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Period Title: Overall Study
STARTED	100
COMPLETED	100
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.1 (14.76)
Sex: Female, Male (Count of Participants)
Female	57 57%
Male	43 43%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Patient's Outcome
Description	Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Measure Participants	100
Recovered without sequelae	73 73%
Ongoing with medical intervention	7 7%
Ongoing with surgical intervention	15 15%
Deceased	3 3%
Other	2 2%

2. Secondary Outcome

Title	Occurence of Adverse Event
Description	Adverse event that occured 72 hours post-operatively
Time Frame	first 72 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Measure Participants	100
Count of Participants [Participants]	19 19%

3. Secondary Outcome

Title	Occurence of Adverse Event
Description	Adverse event that occured between days 4-14 post-operatively
Time Frame	between days 4-14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Measure Participants	100
Count of Participants [Participants]	18 18%

4. Secondary Outcome

Title	Occurence of Adverse Event
Description	Adverse event that occured between days 15-30 post-operatively
Time Frame	Between days 15-30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
Measure Participants	100
Count of Participants [Participants]	15 15%

Adverse Events

Time Frame	Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
Arm/Group Title	Duragen Secure
Arm/Group Description	Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted
All Cause Mortality
	Duragen Secure
	Affected / at Risk (%)	# Events
Total	3/100 (3%)
Serious Adverse Events
	Duragen Secure
	Affected / at Risk (%)	# Events
Total	31/100 (31%)
Blood and lymphatic system disorders
Anemia	1/100 (1%)
Cardiac disorders
Cardiac arrhythmia	1/100 (1%)
Gastrointestinal disorders
Dysphagia	1/100 (1%)
General disorders
Inflammatory reaction	3/100 (3%)
Wound healing disturbance	1/100 (1%)
Death	2/100 (2%)
Weakness worsened	1/100 (1%)
Infections and infestations
Infection	4/100 (4%)
Meningitis	5/100 (5%)
subdural empyema	1/100 (1%)
Shunt infection	1/100 (1%)
cerebral empyema	1/100 (1%)
Septic shock	1/100 (1%)
Pneumonia	1/100 (1%)
Bronchopneumonia	1/100 (1%)
Bladder infection	1/100 (1%)
Wound Infection	1/100 (1%)
Injury, poisoning and procedural complications
Anemia postoperative	1/100 (1%)
Postoperative bleeding	1/100 (1%)
Graft failure	1/100 (1%)
Investigations
Cardiac enzymes increased	1/100 (1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer	1/100 (1%)
Neoplasm recurrence	1/100 (1%)
Nervous system disorders
CSF leakage	2/100 (2%)
Haematoma cerebral	1/100 (1%)
Intracranial haemorrhage	1/100 (1%)
Seizure	4/100 (4%)
Subdural Hygroma	1/100 (1%)
Hydrocephalus	3/100 (3%)
Paraparesis	2/100 (2%)
Hemiparesis	2/100 (2%)
Hemorrhage intracranial	1/100 (1%)
Intracranial hypertension	1/100 (1%)
Dysarthria	1/100 (1%)
Cerebrospinal fluid leakage	3/100 (3%)
Psychiatric disorders
Organic brain syndrome	1/100 (1%)
Renal and urinary disorders
Renal insufficiency	1/100 (1%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	2/100 (2%)
Lung edema	1/100 (1%)
Pleural effusion	2/100 (2%)
Surgical and medical procedures
Brain tumor operation	1/100 (1%)
Vascular disorders
Thrombosis venous deep	1/100 (1%)
Haemorrhage	1/100 (1%)
Other (Not Including Serious) Adverse Events
	Duragen Secure
	Affected / at Risk (%)	# Events
Total	0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.