Back to resultsDuraSeal Sealant Post Market Study
Primary Purpose
Elective Cranial Procedures With Dural Incision
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DuraSeal Dural Sealant System
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Elective Cranial Procedures With Dural Incision
Eligibility Criteria
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
Sites / Locations
- Confluent Surgical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
DuraSeal Dural Sealant System - FDA Approved Device: 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Subjects With Post-operative Surgical Site Infections
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
Full Information
NCT ID
NCT00704340
First Posted
June 23, 2008
Last Updated
August 7, 2017
Sponsor
Integra LifeSciences Corporation
Collaborators
Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT00704340
Brief Title
DuraSeal Sealant Post Market Study
Official Title
DuraSeal Sealant Post Market Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
Collaborators
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Cranial Procedures With Dural Incision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
DuraSeal Dural Sealant System - FDA Approved Device:
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
DuraSeal Dural Sealant System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Standard procedure to obtain intraoperative watertight dural closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Post-operative Surgical Site Infections
Time Frame
30 days
Title
Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Confluent Surgical
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22381303
Citation
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.
Results Reference
derived
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DuraSeal Sealant Post Market Study
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