Spinal Procedure Requiring Dura IncisionNCT00594035
Study to Evaluate Safety and Effectiveness of Spinal Sealant
A study testing Spinal Sealant System in people with Spinal Procedure Requiring Dura Incision, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Procedure Requiring Dura Incision
- What is being tested?
- Spinal Sealant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Apr 2008
- 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
- Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation.
- Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria)
- Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.
Who cannot join
- Active spinal and/or systemic infection
- Patient requires additional spinal surgery within the study time period
- Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure
- Patient has a pre-existing external lumbar CSF drain or internal CSF shunt
- Patient is participating in a clinical trial of another investigational device or drug
- Patient with creatinine > 2.0 mg/dL
Show all 23Show fewer
- Patient with total bilirubin > 2.5 mg/dL
- Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation
- Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery
- Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery
- Patient receiving warfarin or heparin at the time of surgery
- Patient has a diagnosed and documented compromised immune system and/or autoimmune disease
- Patient has has chemotherapy treatment within 6 months prior to, or planned during the study
- Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure
- Patient has known malignancy or other condition with prognosis shorter than 6 months
- Patients with documented history of uncontrolled diabetes
- Patient requires use of synthetic or non-autologous duraplasty material
- Patient has a gap greater than 2mm remaining after primary dural closure
- Patient has undergone laminoplasty decompression
- Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position
- Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level
- The investigator determines that participation in the study may jeopardize the safety or welfare of the patient
- The investigator determines that the patient should not be included in the study for reason(s) not already specified
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 the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
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
- Spinal Procedure Requiring Dura Incision
- Being tested
- Spinal Sealant System, Standard of care
- Keywords
- Spinal procedure, Dura incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Sealant SystemDevice
Standard of careDevice
Also called (i.e. devices intended to provide a watertight closure)
Standard of care: devices intended to provide a watertight closure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Spinal Sealant Receives: Device: Spinal Sealant System |
| 2 | Active comparator | Standard of care Receives: Device: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Watertight Dural Closure
Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.
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 posted15 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionFeb 2008
- Study completionApr 2008
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.
- Other trials for Spinal Procedure Requiring Dura 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Scerbin, Study director, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594035
- Sponsor's protocol ID
- DRS-05-001
- Status last verified
- Aug 2017
- First submitted
- 2 Jan 2008
- Last updated
- 7 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- NCT00594035
- Acronym / sponsor ID
- DRS-05-001
- Conditions
- Spinal Procedure Requiring Dura Incision
- Keywords
- Spinal procedure, Dura incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 3 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
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 |
|---|---|---|
| 1 | Experimental | Device: Spinal Sealant SystemSpinal Sealant |
| 2 | Active comparator | Device: Standard of careStandard of care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation.
- Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria)
- Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds.
Key exclusion criteria (23 listed)
- Active spinal and/or systemic infection
- Patient requires additional spinal surgery within the study time period
- Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure
- Patient has a pre-existing external lumbar CSF drain or internal CSF shunt
- Patient is participating in a clinical trial of another investigational device or drug
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 Sealant System | Device | 1 |
| Standard of careAlso: (i.e. devices intended to provide a watertight closure)Standard of care: devices intended to provide a watertight closure | Device | 2 |
Primary outcome
Watertight Dural Closure
Time frame: Intra-Operative
Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.
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.
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.
Vladimir Scerbin study director
Medtronic - MITG
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 System in people with Spinal Procedure Requiring Dura 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 23 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 3 Dec 2009). 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?
Watertight Dural Closure (time frame: Intra-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.