Spine SurgeryPhase 3NCT00458354
Use of Spinal Sealant System During Spinal Surgery
A Phase 3 study testing Spinal Sealant and Standard Methods of Closing of the Dura in people with Spine Surgery and Excessive Repair, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
1. 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 intraoperatively in patients undergoing spinal surgery. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spine Surgery, Excessive Repair, Spinal Cord Injuries
- What is being tested?
- Spinal Sealant and Standard Methods of Closing of the Dura
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 a spinal procedure that entails a dural incision.
- Patient requires a procedure involving surgical wound classification Class I/Clean (per CDC criteria).
- Patient, or authorized representative, has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
- Intraoperative Criteria: Presence of non-watertight closure, either spontaneously or upon Valsalva maneuver to 20-25 cm H20 for 5-10 seconds.
Who cannot join
- Patient has active spinal and/or systemic infection.
- Patient will require additional spine 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 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 unless discontinued more than 6 weeks prior to surgery (standard perioperative steroids are permitted). For purposes of this protocol, chronic steroid therapy is defined as greater than 4 weeks.
- Patient has documented history of significant coagulopathy with a PTT > 35 sec, PT/ INR >1.2, receiving aspirin, or NSAIDS at the time of surgery. Note: Patients who are receiving cardiovascular prophylaxis are not excluded.
- Patient is receiving warfarin or heparin at the time of surgery (including analogs).
- Patient has a diagnosed and documented compromised immune system and/or autoimmune disease.
- Patient has had chemotherapy treatment within 6 months prior to, or planned during the study (until completion of last follow-up evaluation).
- Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure.
- Patient has a known malignancy or another condition with prognosis shorter than 6 months.
- Patients has a documented history of uncontrolled diabetes.
- The investigator determines that the patient should not be included in the study for reason(s) not already specified.
- Intraoperative Criteria: Patient requires use of a synthetic or non-autologous duraplasty material.
- Intraoperative Criteria: Patient has a gap of greater than 2mm remaining after primary dural closure.
- Patient has undergone laminoplasty decompression.
- Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level.
- Investigator determines that participation in the study may jeopardize the safety or welfare of the patient.
- Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position.
Trial locations and contacts
1 site in 1 country.
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 intraoperatively in patients undergoing 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 up to 90 days post-procedure.
Read the detailed description
The CSF provides a liquid cushion for the brain and spinal cord. The dura holds in the CSF. In order to do spinal surgery, the doctor will cut an opening in the dura. At the end of surgery, the dura must be sealed in order to keep the CSF from leaking out. The doctor will close the dura with stitches and also a piece of tissue taken from another place on your body, to help close the opening. Other standard sealant methods have included the use of Oxicel, Gelfoam, or fibrin glue, but these methods were not designed for closing the dura.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your doctor will see you within 30 days before your operation. At this visit, your medical history will be recorded, and you will be asked questions about any other operations you have had in the past. You will have a complete physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight. You will have a sample of your blood (about 2 tablespoons) collected for kidney and liver function tests to make sure they are functioning properly. You will also be asked to fill out 2 questionnaires about your health, daily activities, and back pain. The questionnaires will take about 20 to 30 minutes to complete. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will receive the Spinal Sealant. You have a 2 out of 3 chance of being randomly assigned to the spinal sealant group. Participants in the other group will receive other standard methods such as the closing of the dura with stitches. However, you will not know which one of the two treatments you receive. Also, (if needed) a piece of your muscle, fat, or other soft tissue may be taken from another place on your body to help seal the opening. Doctors may also use Oxicel, Gelfoam, or fibrin glue to help with the sealing of the dura .
After your already scheduled spinal surgery, your doctor will try to close the opening in the dura, which may be done with stitches alone or, if needed, stitches and a piece of your muscle, fat, or other soft tissue taken from another place on your body. After this try, if there is still some CSF leaking from the dura, you will be assigned to one of the 2 groups for treatment. If you do not have a CSF leak that needs treatment, you will not be able to take part in this study, and you will not have to come back for any study visits.
Participants assigned to the first group will receive treatment with the Spinal Sealant, which will be sprayed over their stitches to close the opening in their dura. The Spinal Sealant is made of 2 plastic-type liquids. When mixed together, a gel is formed that is mostly made up of water. The gel looks and feels sort of like a soft contact lens. After the doctor tries to seal the opening in the dura, the Spinal Sealant is then sprayed over the stitches. It acts like a thin, stretchy covering to help stop the CSF from leaking out through the stitches until the area has properly healed on its own. It is blue-colored, so that the doctor can see where it has been sprayed. Within 1 to 2 months, the gel is naturally broken down by the body and is removed through the urine.
Participants assigned to the second group will be treated with the doctor's choice of other standard treatments to close the opening in their dura. You will not know which group you were assigned to until after the end of your study participation (about 90 days).
While you are still in the hospital (within 7 days after your operation), you will have a physical exam, and your doctor will do a clinical test to check for any CSF leaks. Also, you will have a sample of your blood (about 2 tablespoons) drawn for kidney and liver function tests.
For follow-up, you will be seen by your doctor at about 30 days and again at about 90 days after your operation. It will be very important for you to return to see your doctor at your scheduled follow-up visits, even if you are feeling fine. At the follow-up visits, your doctor will perform a physical exam and check to see how your dura wound is healing and if there is any CSF leakage. You will have a sample of your blood (about 2 tablespoons) collected for kidney and liver function tests. You will also be asked to fill out 2 questionnaires about your health, daily activities, and back pain. The questionnaires will take about 20 to 30 minutes to finish.
Your participation in this study will be over after your 90-day follow-up visit.
THIS IS AN INVESTIGATIONAL STUDY. The Spinal Sealant has been authorized by the FDA for use in research only.
About 158 patients will take part in this multicenter study. Between 15 to 20 participants will be enrolled at M. D. Anderson.
- Being tested
- Spinal Sealant, Standard Methods of Closing of the Dura
- Keywords
- Spinal Sealant, Spinal Sealant System, Dural Repair, Spinal Surgery
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal SealantDevice
Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.
Standard Methods of Closing of the DuraProcedure or surgery
Standard methods such as the closing of the dura with stitches.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Sealant | Experimental | Dural repair with the Spinal Sealant System. Receives: Device: Spinal Sealant |
| Standard Methods | Active comparator | Dural repair with standard methods such as the closing of the dura with stitches. Receives: Procedure: Standard Methods of Closing of the Dura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) success obtaining watertight closure following assigned treatment (Spinal Sealant or control)
Percentage (%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or control) defined as either Success (A watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds); or Failure (A non-watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds). This will be determined intraoperatively.
Measured: Determination in course of surgery with up to 90 day post operative follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startJan 2006
- Primary completionNov 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Confluent Surgical
- Responsible party
- Sponsor
- Investigators
- Ian E. McCutcheon, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458354
- Sponsor's protocol ID
- 2005-0641
- Status last verified
- Oct 2011
- First submitted
- 29 Mar 2007
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. 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
- NCT00458354
- Acronym / sponsor ID
- 2005-0641
- Keywords
- Spinal Sealant, Spinal Sealant System, Dural Repair, Spinal Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Confluent Surgical
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Apr 2007 (estimated)
- Results
- Not posted in the source record
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 intraoperatively in patients undergoing 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 up to 90 days post-procedure.
Detailed description
The CSF provides a liquid cushion for the brain and spinal cord. The dura holds in the CSF. In order to do spinal surgery, the doctor will cut an opening in the dura. At the end of surgery, the dura must be sealed in order to keep the CSF from leaking out. The doctor will close the dura with stitches and also a piece of tissue taken from another place on your body, to help close the opening. Other standard sealant methods have included the use of Oxicel, Gelfoam, or fibrin glue, but these methods were not designed for closing the dura.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your doctor will see you within 30 days before your operation. At this visit, your medical history will be recorded, and you will be asked questions about any other operations you have had in the past. You will have a complete physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight. You will have a sample of your blood (about 2 tablespoons) collected for kidney and liver function tests to make sure they are functioning properly. You will also be asked to fill out 2 questionnaires about your health, daily activities, and back pain. The questionnaires will take about 20 to 30 minutes to complete. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. Participants in one group will receive the Spinal Sealant. You have a 2 out of 3 chance of being randomly assigned to the spinal sealant group. Participants in the other group will receive other standard methods such as the closing of the dura with stitches. However, you will not know which one of the two treatments you receive. Also, (if needed) a piece of your muscle, fat, or other soft tissue may be taken from another place on your body to help seal the opening. Doctors may also use Oxicel, Gelfoam, or fibrin glue to help with the sealing of the dura .
After your already scheduled spinal surgery, your doctor will try to close the opening in the dura, which may be done with stitches alone or, if needed, stitches and a piece of your muscle, fat, or other soft tissue taken from another place on your body. After this try, if there is still some CSF leaking from the dura, you will be assigned to one of the 2 groups for treatment. If you do not have a CSF leak that needs treatment, you will not be able to take part in this study, and you will not have to come back for any study visits.
Participants assigned to the first group will receive treatment with the Spinal Sealant, which will be sprayed over their stitches to close the opening in their dura. The Spinal Sealant is made of 2 plastic-type liquids. When mixed together, a gel is formed that is mostly made up of water. The gel looks and feels sort of like a soft contact lens. After the doctor tries to seal the opening in the dura, the Spinal Sealant is then sprayed over the stitches. It acts like a thin, stretchy covering to help stop the CSF from leaking out through the stitches until the area has properly healed on its own. It is blue-colored, so that the doctor can see where it has been sprayed. Within 1 to 2 months, the gel is naturally broken down by the body and is removed through the urine.
Participants assigned to the second group will be treated with the doctor's choice of other standard treatments to close the opening in their dura. You will not know which group you were assigned to until after the end of your study participation (about 90 days).
While you are still in the hospital (within 7 days after your operation), you will have a physical exam, and your doctor will do a clinical test to check for any CSF leaks. Also, you will have a sample of your blood (about 2 tablespoons) drawn for kidney and liver function tests.
For follow-up, you will be seen by your doctor at about 30 days and again at about 90 days after your operation. It will be very important for you to return to see your doctor at your scheduled follow-up visits, even if you are feeling fine. At the follow-up visits, your doctor will perform a physical exam and check to see how your dura wound is healing and if there is any CSF leakage. You will have a sample of your blood (about 2 tablespoons) collected for kidney and liver function tests. You will also be asked to fill out 2 questionnaires about your health, daily activities, and back pain. The questionnaires will take about 20 to 30 minutes to finish.
Your participation in this study will be over after your 90-day follow-up visit.
THIS IS AN INVESTIGATIONAL STUDY. The Spinal Sealant has been authorized by the FDA for use in research only.
About 158 patients will take part in this multicenter study. Between 15 to 20 participants will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Sealant | Experimental | Device: Spinal SealantDural repair with the Spinal Sealant System. |
| Standard Methods | Active comparator | Procedure: Standard Methods of Closing of the DuraDural repair with standard methods such as the closing of the dura with stitches. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is between 18 and 75 years of age.
- Patient is scheduled for a spinal procedure that entails a dural incision.
- Patient requires a procedure involving surgical wound classification Class I/Clean (per CDC criteria).
- Patient, or authorized representative, has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
- Intraoperative Criteria: Presence of non-watertight closure, either spontaneously or upon Valsalva maneuver to 20-25 cm H20 for 5-10 seconds.
Key exclusion criteria (23 listed)
- Patient has active spinal and/or systemic infection.
- Patient will require additional spine 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 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 SealantSpinal Sealant System which will be sprayed over the stitches to close the opening in the dura. | Device | Spinal Sealant |
| Standard Methods of Closing of the DuraStandard methods such as the closing of the dura with stitches. | Procedure or surgery | Standard Methods |
Primary outcome
Percent (%) success obtaining watertight closure following assigned treatment (Spinal Sealant or control)
Time frame: Determination in course of surgery with up to 90 day post operative follow-up.
Percentage (%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or control) defined as either Success (A watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds); or Failure (A non-watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds). This will be determined intraoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Ian E. McCutcheon, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spinal Sealant and Standard Methods of Closing of the Dura in people with Spine Surgery and Excessive Repair, run by M.D. Anderson Cancer Center 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 5 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 12 Oct 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 obtaining watertight closure following assigned treatment (Spinal Sealant or control) (time frame: Determination in course of surgery with up to 90 day post operative follow-up.). 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 12 Oct 2011.