DuraSeal Sealant Post Market Study
- Conditions
- Elective Cranial Procedures With Dural Incision
- Registration Number
- NCT00704340
- Lead Sponsor
- Integra LifeSciences Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Confluent Surgical
🇺🇸Waltham, Massachusetts, United States
Confluent Surgical🇺🇸Waltham, Massachusetts, United States