DuraSeal Sealant Post Market Study

• ClinicalTrials.gov Identifier: NCT00704340
• Recruitment Status: Completed
• First Posted: June 24, 2008
• Results First Posted: July 28, 2010
• Last Update Posted: September 7, 2017
• Sponsor: Integra LifeSciences Corporation
• Collaborator: Medtronic - MITG
• Information provided by (Responsible Party): Integra LifeSciences Corporation

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).

Condition or disease	Intervention/treatment	Phase
Elective Cranial Procedures With Dural Incision	Device: DuraSeal Dural Sealant System; Other: Standard of Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 237 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: DuraSeal Sealant Post Market Study
• Study Start Date: September 2005
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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.	Device: DuraSeal Dural Sealant System; 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.
Active Comparator: 2; 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.	Other: Standard of Care; 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.; Other Name: Standard procedure to obtain intraoperative watertight dural closure

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room. [ Time Frame: 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 :

1. Percentage of Subjects With Post-operative Surgical Site Infections [ Time Frame: 30 days ]
2. Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Confluent Surgical

Waltham, Massachusetts, United States, 02451

Sponsors and Collaborators

Integra LifeSciences Corporation

Medtronic - MITG

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT00704340 History of Changes
• Other Study ID Numbers: DRS-05-002
• First Posted: June 24, 2008
• Results First Posted: July 28, 2010
• Last Update Posted: September 7, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

Surgical Wound; Wounds and Injuries; Gelatin Sponge, Absorbable; Hemostatics; Coagulants