Cerebrospinal Fluid Leakage, Subdural
Conditions
Keywords
Prevention of CSF leak
Brief summary
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Detailed description
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.
Interventions
DEVICESpinal Sealant
Spinal Sealant System
OTHERStandard of Care
Standard of Care
Sponsors
Medtronic - MITG
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects scheduled for a spinal procedure that requires a dural incision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) | Intra-operative | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-Operative CSF Leaks | 90 Days | 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 |
| Incidence of Post-Operative Surgical Site Infections (SSIs) | 90 Days | •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). |
Countries
United States
Participant flow
Recruitment details
The first subject was consented on May 15, 2007. The last subject visit occurred on August 12, 2009.
Pre-assignment details
Washout study, no run-in or wash-out periods.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Sealant DuraSeal Spinal Sealant System | 74 |
| Control Standard of care methods used as an adjunct to sutured dural repair. | 24 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Spinal Sealant | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 23 Participants | 92 Participants |
| Age (Statistics) | 44.25 years STANDARD_DEVIATION 13.06 | 44.70 years STANDARD_DEVIATION 11.44 | 44.36 years STANDARD_DEVIATION 12.62 |
| Region of Enrollment United States | 74 participants | 24 participants | 98 participants |
| Sex: Female, Male Female | 30 Participants | 9 Participants | 39 Participants |
| Sex: Female, Male Male | 44 Participants | 15 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 64 / 73 | 20 / 24 |
| serious Total, serious adverse events | 17 / 73 | 5 / 24 |
Outcome results
Primary
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)
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.
Time frame: Intra-operative
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Sealant | Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) | 98.0 percentage of participants |
| Control | Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) | 79.2 percentage of participants |
Other Pre-specified
Incidence of Post-Operative CSF Leaks
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
Time frame: 90 Days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Sealant | Incidence of Post-Operative CSF Leaks | 11 percentage of participants |
| Control | Incidence of Post-Operative CSF Leaks | 12.5 percentage of participants |
Other Pre-specified
Incidence of Post-Operative Surgical Site Infections (SSIs)
•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).
Time frame: 90 Days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Sealant | Incidence of Post-Operative Surgical Site Infections (SSIs) | 6.8 percentage of participants |
| Control | Incidence of Post-Operative Surgical Site Infections (SSIs) | 12.5 percentage of participants |