Cerebrospinal Fluid Leakage, SubduralNCT00444067
Study to Evaluate Safety & Effectiveness of Spinal Sealant
A study testing Spinal Sealant in people with Cerebrospinal Fluid Leakage, Subdural, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrospinal Fluid Leakage, Subdural
- What is being tested?
- Spinal Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 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
- Subjects scheduled for a spinal procedure that requires a dural incision
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Confluent Surgical, Inc.
Bedford, Massachusetts, 01730
About this study
Official title: A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Read the detailed description
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.
- Conditions
- Cerebrospinal Fluid Leakage, Subdural
- Being tested
- Spinal Sealant, Standard of Care
- Keywords
- Prevention of CSF leak
- Medical subject headings
- Subdural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal SealantDevice
Spinal Sealant System
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Spinal Sealant System | Experimental | Spinal Sealant System Receives: Device: Spinal Sealant |
| Standard of Care | Active comparator | Standard of care methods as an adjunct to sutured dural repair Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)
Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as:
A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 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 Cerebrospinal Fluid Leakage, SubduralStudies 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Jen Doyle, Study director, Conlfuent Surgical/Covidien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444067
- Sponsor's protocol ID
- DS3-06-002
- Status last verified
- Sep 2014
- First submitted
- 6 Mar 2007
- Last updated
- 7 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wright NM, Park J, Tew JM, Kim KD, Shaffrey ME, Cheng J, Choudhri H, Krishnaney AA, Graham RS, Mendel E, Simmons N. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine (Phila Pa 1976). 2015 Apr 15;40(8):505-13. doi: 10.1097/BRS.0000000000000810.
PubMed 25646746
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
- A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
- ClinicalTrials.gov ID
- NCT00444067
- Acronym / sponsor ID
- DS3-06-002
- Conditions
- Cerebrospinal Fluid Leakage, Subdural
- Keywords
- Prevention of CSF leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Mar 2007 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Detailed description
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Sealant System | Experimental | Device: Spinal SealantSpinal Sealant System |
| Standard of Care | Active comparator | Other: Standard of CareStandard of care methods as an adjunct to sutured dural repair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects scheduled for a spinal procedure that requires a dural incision
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 |
|---|---|---|
| Spinal SealantSpinal Sealant System | Device | Spinal Sealant System |
| Standard of CareStandard of Care | Other | Standard of Care |
Primary outcome
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)
Time frame: Intra-operative
Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.
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 25646746Wright NM, Park J, Tew JM, Kim KD, Shaffrey ME, Cheng J, Choudhri H, Krishnaney AA, Graham RS, Mendel E, Simmons N. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study. Spine (Phila Pa 1976). 2015 Apr 15;40(8):505-13. doi: 10.1097/BRS.0000000000000810.
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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.
Jen Doyle study director
Conlfuent Surgical/Covidien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Sealant in people with Cerebrospinal Fluid Leakage, Subdural, 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 1 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 21 Aug 2012). 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?
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) (time frame: Intra-operative). 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 NCT00444067, 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.