Trial Outcomes & Findings for Study to Evaluate Safety and Effectiveness of Spinal Sealant (NCT NCT00594035)
NCT ID: NCT00594035
Last Updated: 2017-09-07
Results Overview
Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
158 participants
Primary outcome timeframe
Intra-Operative
Results posted on
2017-09-07
Participant Flow
Subjects scheduled for spinal procedures requiring a dural incision were considered for study participation. The Study involved 24 investigational sites within the United States. Subjects were recruited from neurosurgery practices between the period of 01 September 2005 (first subject consented) to 06 Feb 2008 (last visit date).
Enrollment was considered the point of randomization. Subjects were randomized intra-operatively after confirmation that all pre-operative and intra-operative eligibility criteria had been met.
Participant milestones
| Measure |
Spinal Sealant
Subjects that recieve DuraSeal Spinal Sealant
|
Standard of Care
Subjects who receive standard or care meathods of dural sealing
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
56
|
|
Overall Study
COMPLETED
|
100
|
53
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Spinal Sealant
Subjects that recieve DuraSeal Spinal Sealant
|
Standard of Care
Subjects who receive standard or care meathods of dural sealing
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Subject transferred to nursing home
|
0
|
1
|
|
Overall Study
Subject couldn't return due to job
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Safety and Effectiveness of Spinal Sealant
Baseline characteristics by cohort
| Measure |
Spinal Sealant
n=102 Participants
Subjects that recieve DuraSeal Spinal Sealant
|
Standard of Care
n=56 Participants
Subjects who receive standard or care meathods of dural sealing
|
Total
n=158 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
|
89 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
56 participants
n=7 Participants
|
158 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-OperativeNumber of subjects displaying a watertight dural closure after assigned treatment intra-operatively.
Outcome measures
| Measure |
Spinal Sealant
n=102 Participants
Subjects that recieve DuraSeal Spinal Sealant
|
Standard of Care
n=56 Participants
Subjects who receive standard or care meathods of dural sealing
|
|---|---|---|
|
Watertight Dural Closure
|
102 Participants
|
36 Participants
|
Adverse Events
Spinal Sealant
Serious events: 30 serious events
Other events: 65 other events
Deaths: 0 deaths
Standard of Care
Serious events: 10 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Spinal Sealant
n=102 participants at risk
Subjects that recieve DuraSeal Spinal Sealant
|
Standard of Care
n=56 participants at risk
Subjects who receive standard or care meathods of dural sealing
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Cerebrospinal Fistula
|
2.0%
2/102 • Number of events 2 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Infections and infestations
Diverticulitis
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Graft Complication
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Headache
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
4.9%
5/102 • Number of events 5 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Loss of Proprioception
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Nerve Injury
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Paralysis
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Paraplegia
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
2.0%
2/102 • Number of events 2 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
4.9%
5/102 • Number of events 5 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
3.6%
2/56 • Number of events 2 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
General disorders
Pyrexia
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Radiculopathy
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.0%
2/102 • Number of events 2 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Sensory Loss
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Syncope Vasovagal
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Renal and urinary disorders
Urinary Retention
|
2.0%
2/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/102 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.98%
1/102 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
Other adverse events
| Measure |
Spinal Sealant
n=102 participants at risk
Subjects that recieve DuraSeal Spinal Sealant
|
Standard of Care
n=56 participants at risk
Subjects who receive standard or care meathods of dural sealing
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
8/102 • Number of events 8 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.9%
7/102 • Number of events 7 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Investigations
Body Temperature Increased
|
45.1%
46/102 • Number of events 48 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
35.7%
20/56 • Number of events 23 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Gastrointestinal disorders
Constipation
|
8.8%
9/102 • Number of events 9 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Headache
|
5.9%
6/102 • Number of events 7 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
8.9%
5/56 • Number of events 5 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.9%
5/102 • Number of events 5 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Vascular disorders
Hypertension
|
3.9%
4/102 • Number of events 4 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Hypoaesthesia
|
11.8%
12/102 • Number of events 16 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
12.5%
7/56 • Number of events 8 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Hyporeflexia
|
6.9%
7/102 • Number of events 7 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
11.8%
12/102 • Number of events 14 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
3.6%
2/56 • Number of events 4 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Infections and infestations
Incision Site Infection
|
2.0%
2/102 • Number of events 2 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Psychiatric disorders
Insomnia
|
3.9%
4/102 • Number of events 4 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.9%
6/102 • Number of events 6 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
3.6%
2/56 • Number of events 2 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Neuralgia
|
4.9%
5/102 • Number of events 5 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
0.00%
0/56 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain In extremity
|
5.9%
6/102 • Number of events 6 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
7.1%
4/56 • Number of events 4 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Nervous system disorders
Paraesthesia
|
3.9%
4/102 • Number of events 4 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
5.4%
3/56 • Number of events 3 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
General disorders
Pyrexia
|
18.6%
19/102 • Number of events 23 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
23.2%
13/56 • Number of events 14 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Renal and urinary disorders
Urinary Retention
|
10.8%
11/102 • Number of events 13 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
1.8%
1/56 • Number of events 1 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
|
Infections and infestations
Urinary Tract Infection
|
10.8%
11/102 • Number of events 11 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
7.1%
4/56 • Number of events 4 • Subjects were followed and adverse events were collected for 90 days after surgery.
|
Additional Information
Director, Medical Affairs
Integra LifeSciences
Phone: 609-275-0500
Results disclosure agreements
- Principal investigator is a sponsor employee * The sponsor can review results at least 30 days prior to public release, and at the request of Sponsor, the PI will withhold submission for an additional period, not to exceed 90 days. * The first publication of the study results shall be made in conjunction with a joint, multi-center publication of the results. If a multi-center publication is not submitted within 12 months after the conclusion of the Study, the PIs may publish the results from their individual site.
- Publication restrictions are in place
Restriction type: OTHER