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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Sealant System | Experimental | Spinal Sealant System |
|
| Standard of Care | Active Comparator | Standard of care methods as an adjunct to sutured dural repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Sealant | Device | Spinal Sealant System |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jen Doyle | Conlfuent Surgical/Covidien | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Confluent Surgical, Inc. | Bedford | Massachusetts | 01730 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25646746 | Derived | Wright NM, Park J, Tew JM, Kim KD, Shaffrey ME, Cheng J, Choudhri H, Krishnaney AA, Graham RS, Mendel E, Simmons N. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine (Phila Pa 1976). 2015 Apr 15;40(8):505-13. doi: 10.1097/BRS.0000000000000810. |
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Washout study, no run-in or wash-out periods.
The first subject was consented on May 15, 2007. The last subject visit occurred on August 12, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Sealant | DuraSeal Spinal Sealant System |
| FG001 | Control | Standard of care methods used as an adjunct to sutured dural repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Sealant | DuraSeal Spinal Sealant System |
| BG001 | Control | Standard of care methods used as an adjunct to sutured dural repair. |
| 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Intra-operative |
|
90 Days post-procedure
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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 | Spinal Sealant | DuraSeal Spinal Sealant System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders | MedDRA (9.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Medical Affairs | Integra LifeSciences | 609-275-0500 |
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| ID | Term |
|---|---|
| D013353 | Subdural Effusion |
| ID | Term |
|---|---|
| D020819 | Perimeningeal Infections |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D001927 | Brain Diseases |
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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 of Care |
|
| 90 Days |
| 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). | 90 Days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age (Statistics) | Mean | Standard Deviation | years |
|
| Control |
Standard of care methods used as an adjunct to sutured dural repair. |
|
|
| 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:
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 90 Days |
|
|
|
| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 90 Days |
|
|
|
| 17 |
| 73 |
| 64 |
| 73 |
| EG001 | Control | Standard of care methods used as an adjunct to sutured dural repair. | 5 | 24 | 20 | 24 |
| Pain | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Meningitis Bacterial | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Chemical Meningitis | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Incision Site Complication | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Incision Site Haematoma | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Meningitis Chemical | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Cerebrospinal Fistula | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Grand Mal Convulsion | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Loss of Proprioception | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Mental Disorder | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| General Disorders and Administration Site Conditions | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (9.1) | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Skin and Subcutaneous Disorders | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |