Elective Cranial Procedures With Dural Incision
Conditions
Brief summary
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).
Interventions
DEVICEDuraSeal Dural Sealant System
The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel. DuraSeal should only be used with autologous duraplasty material.
OTHERStandard of Care
Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator.
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
* Patient is between 18 and 75 years of age * Patient is scheduled for an elective cranial procedure that entails a dural incision * Evidence of intraoperative non-watertight closure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room. | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Post-operative Surgical Site Infections | 30 days | — |
| Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak | 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 |
Countries
United States
Participant flow
Recruitment details
First subject was enrolled on September 12, 2005, last subject visit was May 20, 2009.
Pre-assignment details
Randomized study, no washout or run-in period.
Participants by arm
| Arm | Count |
|---|---|
| DuraSeal DuraSeal Dural Sealant System - FDA Approved Device | 120 |
| Control Standard of Care (control) | 117 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Control | DuraSeal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 12 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants | 108 Participants | 210 Participants |
| Age, Continuous | 48.2 years STANDARD_DEVIATION 13.5 | 49.6 years STANDARD_DEVIATION 14.1 | 48.9 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 117 participants | 120 participants | 237 participants |
| Sex: Female, Male Female | 74 Participants | 78 Participants | 152 Participants |
| Sex: Female, Male Male | 43 Participants | 42 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 117 |
| serious Total, serious adverse events | 15 / 120 | 19 / 117 |
Outcome results
Primary
Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DuraSeal | 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 |
| 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. | 7.7 percent of subjects |
Comparison: The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.p-value: 0.613t-test, 2 sided
Secondary
Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak
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
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DuraSeal | Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak | 0.8 percent of subjects |
| Control | Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak | 1.7 percent of subjects |
p-value: 0.619t-test, 2 sided
Secondary
Percentage of Subjects With Post-operative Surgical Site Infections
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DuraSeal | Percentage of Subjects With Post-operative Surgical Site Infections | 1.7 percent of subjects |
| Control | Percentage of Subjects With Post-operative Surgical Site Infections | 2.6 percent of subjects |
p-value: 0.681t-test, 2 sided