Elective Cranial Procedures With Dural IncisionNCT00704340
DuraSeal Sealant Post Market Study
A study testing DuraSeal Dural Sealant System in people with Elective Cranial Procedures With Dural Incision, run by Integra LifeSciences Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Elective Cranial Procedures With Dural Incision
- What is being tested?
- DuraSeal Dural Sealant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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).
- Being tested
- DuraSeal Dural Sealant System, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraSeal Dural Sealant SystemDevice
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 CareOther
Also called Standard procedure to obtain intraoperative watertight dural closure
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Device: DuraSeal Dural Sealant System |
| 2 | Active comparator | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
Percentage of Subjects With Post-operative Surgical Site Infections
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startSep 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cranial Procedures With Dural IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704340
- Sponsor's protocol ID
- DRS-05-002
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2008
- Last updated
- 7 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22381303
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DuraSeal Sealant Post Market Study
- ClinicalTrials.gov ID
- NCT00704340
- Acronym / sponsor ID
- DRS-05-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG
- Study start
- Sep 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Posted 28 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: DuraSeal Dural Sealant SystemDuraSeal 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. |
| 2 | Active comparator | Other: Standard of CareStandard 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuraSeal Dural Sealant SystemThe 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. | Device | 1 |
| Standard of CareAlso: Standard procedure to obtain intraoperative watertight dural closureStandard 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 | 2 |
Primary outcome
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.
2 secondary outcomes
Percentage of Subjects With Post-operative Surgical Site Infections
Time frame: 30 days
Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22381303Osbun 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DuraSeal Dural Sealant System in people with Elective Cranial Procedures With Dural Incision, run by Integra LifeSciences Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00704340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.