Trial Outcomes & Findings for DuraSeal Sealant Post Market Study (NCT NCT00704340)

Last Updated: 2017-09-07

Results Overview

Surgical Wound Complications; * Superficial incisional surgical site infection (SSI) * Deep incisional SSI * Organ/Space SSI * Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery * Poor wound healing Central Nervous System Events; * Cerebrospinal Fluid (CSF) leak * Hydrocephalus * Bacterial meningitis * Aseptic meningitis In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted.

Recruitment status

COMPLETED

Study phase

Target enrollment

237 participants

Primary outcome timeframe

30 days

Results posted on

2017-09-07

Participant Flow

First subject was enrolled on September 12, 2005, last subject visit was May 20, 2009.

Randomized study, no washout or run-in period.

Participant milestones

Participant milestones
Measure	DuraSeal DuraSeal Dural Sealant System - FDA Approved Device	Control Standard of Care (control)
Overall Study STARTED	120	117
Overall Study COMPLETED	118	115
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DuraSeal DuraSeal Dural Sealant System - FDA Approved Device	Control Standard of Care (control)
Overall Study Lost to Follow-up	2	1
Overall Study Death	0	1

Baseline Characteristics

DuraSeal Sealant Post Market Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DuraSeal n=120 Participants DuraSeal Dural Sealant System - FDA Approved Device	Control n=117 Participants Standard of Care (control)	Total n=237 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	108 Participants n=5 Participants	102 Participants n=7 Participants	210 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 14.1 • n=5 Participants	48.2 years STANDARD_DEVIATION 13.5 • n=7 Participants	48.9 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	74 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants
Region of Enrollment United States	120 participants n=5 Participants	117 participants n=7 Participants	237 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	DuraSeal n=120 Participants DuraSeal Dural Sealant System - FDA Approved Device	Control n=117 Participants Standard of Care (control)
Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.	5.8 percent of subjects Interval 2.4 to 11.6	7.7 percent of subjects Interval 3.6 to 14.1

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	DuraSeal n=120 Participants DuraSeal Dural Sealant System - FDA Approved Device	Control n=117 Participants Standard of Care (control)
Percentage of Subjects With Post-operative Surgical Site Infections	1.7 percent of subjects Interval 0.2 to 5.9	2.6 percent of subjects Interval 0.5 to 7.3

SECONDARY outcome

Timeframe: 30 days

As determined from clinical diagnosis by one of the following methods: * CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation * CSF leak confirmation by diagnostic testing within 30 days post-operation * CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation

Outcome measures

Outcome measures
Measure	DuraSeal n=120 Participants DuraSeal Dural Sealant System - FDA Approved Device	Control n=117 Participants Standard of Care (control)
Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak	0.8 percent of subjects Interval 0.0 to 4.6	1.7 percent of subjects Interval 0.2 to 6.0

Adverse Events

DuraSeal

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DuraSeal n=120 participants at risk DuraSeal Dural Sealant System - FDA Approved Device	Control n=117 participants at risk Standard of Care (control)
Nervous system disorders Acute Gait Dysfunction/Readmission	0.83% 1/120 • Number of events 1	0.00% 0/117
Nervous system disorders evacuation of epidural hematoma	0.83% 1/120 • Number of events 1	0.00% 0/117
Cardiac disorders pulmonary embolus	0.00% 0/120	1.7% 2/117 • Number of events 2
Infections and infestations C. Difficile	0.00% 0/120	0.85% 1/117 • Number of events 1
Cardiac disorders Transient Ischemic Attack (T.I.A.)	0.00% 0/120	0.85% 1/117 • Number of events 1
Nervous system disorders Seizure	0.83% 1/120 • Number of events 1	2.6% 3/117 • Number of events 3
Infections and infestations Deep Incisional SSI	1.7% 2/120 • Number of events 2	0.00% 0/117
Infections and infestations Superficial Incisional SSI	0.00% 0/120	2.6% 3/117 • Number of events 3
Nervous system disorders Headache and intractable nausea/vomiting	0.00% 0/120	0.85% 1/117 • Number of events 2
Nervous system disorders Headache	2.5% 3/120 • Number of events 3	0.00% 0/117
Cardiac disorders Cerebrovascular Accident (C.V.A.)- also known as stroke	0.83% 1/120 • Number of events 1	0.85% 1/117 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/120	0.85% 1/117 • Number of events 1
General disorders Pancreatitis	0.00% 0/120	0.85% 1/117 • Number of events 1
Nervous system disorders Cerebral hemmorhage	2.5% 3/120 • Number of events 3	0.85% 1/117 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Metastatic melanoma	0.83% 1/120 • Number of events 1	0.00% 0/117
Blood and lymphatic system disorders Blood clot	0.83% 1/120 • Number of events 1	0.00% 0/117
Infections and infestations Aseptic meningitis	0.00% 0/120	0.85% 1/117 • Number of events 1
Blood and lymphatic system disorders Central diabetes insipidus	0.00% 0/120	0.85% 1/117 • Number of events 1
Blood and lymphatic system disorders Deep Vein Thrombosis	0.00% 0/120	0.85% 1/117 • Number of events 1
Nervous system disorders CSF leak	0.83% 1/120 • Number of events 1	0.85% 1/117 • Number of events 1
Infections and infestations Late incisional SSI	0.83% 1/120 • Number of events 1	0.00% 0/117
Nervous system disorders headache/double-vision	0.00% 0/120	0.85% 1/117 • Number of events 1
Nervous system disorders left hemiplegia	0.83% 1/120 • Number of events 1	0.00% 0/117
Gastrointestinal disorders nausea/vomiting	0.00% 0/120	0.85% 1/117 • Number of events 1
Nervous system disorders hydrocephalus	0.83% 1/120 • Number of events 1	0.00% 0/117
Nervous system disorders cerebral vasospasm	0.00% 0/120	0.85% 1/117 • Number of events 1
Blood and lymphatic system disorders Bacteremia	0.00% 0/120	0.85% 1/117 • Number of events 1
Nervous system disorders cerebral edema	0.83% 1/120 • Number of events 1	0.00% 0/117
Nervous system disorders brain tumor	0.83% 1/120 • Number of events 1	0.00% 0/117
Nervous system disorders severe neurological deficit post-op	0.83% 1/120 • Number of events 1	0.00% 0/117

Other adverse events

Adverse event data not reported

Additional Information

Director, Medical Affairs

Integra LifeSciences

Phone: 609-275-0500

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60