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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DuraSeal Dural Sealant System - FDA Approved Device: The DuraSealâ„¢ 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. |
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| 2 | Active Comparator | Standard of Care (control): 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DuraSeal Dural Sealant System | Device | The DuraSealâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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;
Central Nervous System Events;
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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Post-operative Surgical Site Infections | 30 days | |
| Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak | As determined from clinical diagnosis by one of the following methods:
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Confluent Surgical | Waltham | Massachusetts | 02451 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22381303 | Derived | Osbun JW, Ellenbogen RG, Chesnut RM, Chin LS, Connolly PJ, Cosgrove GR, Delashaw JB Jr, Golfinos JG, Greenlee JD, Haines SJ, Jallo J, Muizelaar JP, Nanda A, Shaffrey M, Shah MV, Tew JM Jr, van Loveren HR, Weinand ME, White JA, Wilberger JE. A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. World Neurosurg. 2012 Nov;78(5):498-504. doi: 10.1016/j.wneu.2011.12.011. Epub 2011 Dec 10. |
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Randomized study, no washout or run-in period.
First subject was enrolled on September 12, 2005, last subject visit was May 20, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | DuraSeal | DuraSeal Dural Sealant System - FDA Approved Device |
| FG001 | Control | Standard of Care (control) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DuraSeal | DuraSeal Dural Sealant System - FDA Approved Device |
| BG001 | Control | Standard of Care (control) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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;
Central Nervous System Events;
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. | Posted | Number | 95% Confidence Interval | percent of subjects | 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DuraSeal | DuraSeal Dural Sealant System - FDA Approved Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Gait Dysfunction/Readmission | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Medical Affairs | Integra LifeSciences | 609-275-0500 |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | 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. |
|
|
| 30 days |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Control | Standard of Care (control) |
|
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| Secondary | Percentage of Subjects With Post-operative Surgical Site Infections | Posted | Number | 95% Confidence Interval | percent of subjects | 30 days |
|
|
|
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| Secondary | Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak | As determined from clinical diagnosis by one of the following methods:
| Posted | Number | 95% Confidence Interval | percent of subjects | 30 days |
|
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|
|
| 15 |
| 120 |
| 0 |
| 120 |
| EG001 | Control | Standard of Care (control) | 19 | 117 | 0 | 117 |
| evacuation of epidural hematoma | Nervous system disorders | Systematic Assessment |
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| pulmonary embolus | Cardiac disorders | Systematic Assessment |
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| C. Difficile | Infections and infestations | Systematic Assessment |
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| Transient Ischemic Attack (T.I.A.) | Cardiac disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Deep Incisional SSI | Infections and infestations | Non-systematic Assessment |
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| Superficial Incisional SSI | Infections and infestations | Non-systematic Assessment |
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| Headache and intractable nausea/vomiting | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Cerebrovascular Accident (C.V.A.)- also known as stroke | Cardiac disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pancreatitis | General disorders | Systematic Assessment |
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| Cerebral hemmorhage | Nervous system disorders | Systematic Assessment |
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| Malignant Metastatic melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Blood clot | Blood and lymphatic system disorders | Systematic Assessment |
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| Aseptic meningitis | Infections and infestations | Systematic Assessment |
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| Central diabetes insipidus | Blood and lymphatic system disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
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| CSF leak | Nervous system disorders | Systematic Assessment |
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| Late incisional SSI | Infections and infestations | Non-systematic Assessment |
|
| headache/double-vision | Nervous system disorders | Non-systematic Assessment |
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| left hemiplegia | Nervous system disorders | Non-systematic Assessment |
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| nausea/vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| hydrocephalus | Nervous system disorders | Systematic Assessment |
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| cerebral vasospasm | Nervous system disorders | Systematic Assessment |
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| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
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| cerebral edema | Nervous system disorders | Systematic Assessment |
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| brain tumor | Nervous system disorders | Systematic Assessment |
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| severe neurological deficit post-op | Nervous system disorders | Non-systematic Assessment |
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