Trial Outcomes & Findings for Study to Evaluate Safety & Effectiveness of Spinal Sealant (NCT NCT00444067)
NCT ID: NCT00444067
Last Updated: 2017-09-07
Results Overview
Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.
COMPLETED
NA
98 participants
Intra-operative
2017-09-07
Participant Flow
The first subject was consented on May 15, 2007. The last subject visit occurred on August 12, 2009.
Washout study, no run-in or wash-out periods.
Participant milestones
| Measure |
Spinal Sealant
DuraSeal Spinal Sealant System
|
Control
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
24
|
|
Overall Study
COMPLETED
|
74
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Spinal Sealant
DuraSeal Spinal Sealant System
|
Control
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Safety & Effectiveness of Spinal Sealant
Baseline characteristics by cohort
| Measure |
Spinal Sealant
n=74 Participants
DuraSeal Spinal Sealant System
|
Control
n=24 Participants
Standard of care methods used as an adjunct to sutured dural repair.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
24 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Age (Statistics)
|
44.25 years
STANDARD_DEVIATION 13.06 • n=99 Participants
|
44.70 years
STANDARD_DEVIATION 11.44 • n=107 Participants
|
44.36 years
STANDARD_DEVIATION 12.62 • n=206 Participants
|
PRIMARY outcome
Timeframe: Intra-operativePopulation: The primary analysis for the primary efficacy endpoint was performed using a two-sided Fisher's Exact Test to test for a difference in the true success rates in obtaining a watertight closure between treatments.
Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.
Outcome measures
| Measure |
Spinal Sealant
n=74 Participants
DuraSeal Spinal Sealant System
|
Control
n=24 Participants
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)
|
98.0 percentage of participants
Interval 92.7 to 100.0
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 DaysPopulation: Fisher's Exact Test was used to test for a difference in the proportions of subjects with CSF leaks between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.
Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods: * CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or * CSF leak confirmation by diagnostic testing within 90 days post-procedure; or * CSF leak confirmation by clinical evaluation within 90 days post-procedure
Outcome measures
| Measure |
Spinal Sealant
n=73 Participants
DuraSeal Spinal Sealant System
|
Control
n=24 Participants
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Incidence of Post-Operative CSF Leaks
|
11 percentage of participants
Interval 4.9 to 20.5
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 DaysPopulation: Fisher's Exact Test was used to test for a difference in the proportions of subjects with SSIs between the two treatments. Confidence intervals were produced based on the observed percentage and also on the percentage estimated using the Kaplan-Meier method.
•Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space).
Outcome measures
| Measure |
Spinal Sealant
n=73 Participants
DuraSeal Spinal Sealant System
|
Control
n=24 Participants
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Incidence of Post-Operative Surgical Site Infections (SSIs)
|
6.8 percentage of participants
Interval 2.9 to 15.7
|
12.5 percentage of participants
Interval 4.4 to 35.2
|
Adverse Events
Spinal Sealant
Control
Serious adverse events
| Measure |
Spinal Sealant
n=73 participants at risk
DuraSeal Spinal Sealant System
|
Control
n=24 participants at risk
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
General disorders
Pain
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/73 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
|
Infections and infestations
Meningitis Bacterial
|
0.00%
0/73 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
|
Infections and infestations
Pneumonia
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Chemical Meningitis
|
2.7%
2/73 • Number of events 2 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Meningitis Chemical
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
4.1%
3/73 • Number of events 3 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/73 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Nervous system disorders
Cerebrospinal Fistula
|
2.7%
2/73 • Number of events 2 • 90 Days post-procedure
|
8.3%
2/24 • Number of events 2 • 90 Days post-procedure
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/73 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
|
Nervous system disorders
Headache
|
2.7%
2/73 • Number of events 2 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Nervous system disorders
Loss of Proprioception
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Psychiatric disorders
Mental Disorder
|
1.4%
1/73 • Number of events 1 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
Other adverse events
| Measure |
Spinal Sealant
n=73 participants at risk
DuraSeal Spinal Sealant System
|
Control
n=24 participants at risk
Standard of care methods used as an adjunct to sutured dural repair.
|
|---|---|---|
|
Eye disorders
Eye Disorders
|
5.5%
4/73 • Number of events 4 • 90 Days post-procedure
|
12.5%
3/24 • Number of events 3 • 90 Days post-procedure
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
15.1%
11/73 • Number of events 11 • 90 Days post-procedure
|
33.3%
8/24 • Number of events 8 • 90 Days post-procedure
|
|
General disorders
General Disorders and Administration Site Conditions
|
26.0%
19/73 • Number of events 19 • 90 Days post-procedure
|
29.2%
7/24 • Number of events 7 • 90 Days post-procedure
|
|
Infections and infestations
Infections and Infestations
|
19.2%
14/73 • Number of events 14 • 90 Days post-procedure
|
29.2%
7/24 • Number of events 7 • 90 Days post-procedure
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
28.8%
21/73 • Number of events 21 • 90 Days post-procedure
|
29.2%
7/24 • Number of events 7 • 90 Days post-procedure
|
|
Investigations
Investigations
|
28.8%
21/73 • Number of events 21 • 90 Days post-procedure
|
29.2%
7/24 • Number of events 7 • 90 Days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
37.0%
27/73 • Number of events 27 • 90 Days post-procedure
|
29.2%
7/24 • Number of events 7 • 90 Days post-procedure
|
|
Nervous system disorders
Nervous System Disorders
|
52.1%
38/73 • Number of events 94 • 90 Days post-procedure
|
54.2%
13/24 • Number of events 34 • 90 Days post-procedure
|
|
Psychiatric disorders
Psychiatric Disorders
|
8.2%
6/73 • Number of events 6 • 90 Days post-procedure
|
8.3%
2/24 • Number of events 2 • 90 Days post-procedure
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
13.7%
10/73 • Number of events 10 • 90 Days post-procedure
|
25.0%
6/24 • Number of events 6 • 90 Days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
5.5%
4/73 • Number of events 5 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Disorders
|
6.8%
5/73 • Number of events 6 • 90 Days post-procedure
|
0.00%
0/24 • 90 Days post-procedure
|
|
Vascular disorders
Vascular Disorders
|
12.3%
9/73 • Number of events 9 • 90 Days post-procedure
|
4.2%
1/24 • Number of events 1 • 90 Days post-procedure
|
Additional Information
Director, Medical Affairs
Integra LifeSciences
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 30 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 PI may publish the results from their individual site.
- Publication restrictions are in place
Restriction type: OTHER