Spinal Procedure Requiring Dura Incision
Conditions
Keywords
Spinal procedure, Dura incision
Brief summary
To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
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 System
DEVICEStandard of care
Standard of care: devices intended to provide a watertight closure
Sponsors
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
* Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation. * Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria) * Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.
Exclusion criteria
* Active spinal and/or systemic infection * Patient requires additional spinal surgery within the study time period * Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure * Patient has a pre-existing external lumbar CSF drain or internal CSF shunt * Patient is participating in a clinical trial of another investigational device or drug * Patient with creatinine \> 2.0 mg/dL * Patient with total bilirubin \> 2.5 mg/dL * Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation * Patient has been treated with chronic steroid therapy (\>4 weeks) unless discontinued more than 6 weeks prior to surgery * Patient has documented history or significant coagulopathy with a PTT \>35 sec, PT/INR \>1.2, receiving asprin, or NSAIDS at the time of surgery * Patient receiving warfarin or heparin at the time of surgery * Patient has a diagnosed and documented compromised immune system and/or autoimmune disease * Patient has has chemotherapy treatment within 6 months prior to, or planned during the study * Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure * Patient has known malignancy or other condition with prognosis shorter than 6 months * Patients with documented history of uncontrolled diabetes * Patient requires use of synthetic or non-autologous duraplasty material * Patient has a gap greater than 2mm remaining after primary dural closure * Patient has undergone laminoplasty decompression * Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position * Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level * The investigator determines that participation in the study may jeopardize the safety or welfare of the patient * The investigator determines that the patient should not be included in the study for reason(s) not already specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Watertight Dural Closure | Intra-Operative | Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Sealant Subjects that recieve DuraSeal Spinal Sealant | 102 |
| Standard of Care Subjects who receive standard or care meathods of dural sealing | 56 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Subject couldn't return due to job | 0 | 1 |
| Overall Study | Subject transferred to nursing home | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | Spinal Sealant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 13 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 89 Participants | 141 Participants |
| Age, Continuous | 42.3 years STANDARD_DEVIATION 14.5 | 47.7 years STANDARD_DEVIATION 13.6 | 45.8 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment United States | 56 participants | 102 participants | 158 participants |
| Sex: Female, Male Female | 30 Participants | 54 Participants | 84 Participants |
| Sex: Female, Male Male | 26 Participants | 48 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 65 / 102 | 41 / 56 |
| serious Total, serious adverse events | 30 / 102 | 10 / 56 |
Outcome results
Primary
Watertight Dural Closure
Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.
Time frame: Intra-Operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Sealant | Watertight Dural Closure | 102 Participants |
| Standard of Care | Watertight Dural Closure | 36 Participants |