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Completed

NCT Number: NCT00704340

DuraSeal Sealant Post Market Study

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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Key information

Conditions

Elective Cranial Procedures With Dural Incision

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Confluent Surgical

Waltham, Massachusetts, 02451, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DuraSeal Dural Sealant System

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. DuraSeal should only be used with autologous duraplasty material.

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.

Other names: Standard procedure to obtain intraoperative watertight dural closure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Medtronic - MITG

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 24, 2008
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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