Chiari MalformationPhase 3NCT00741858
Duragen Versus Duraguard in Chiari Surgery
A Phase 3 study testing Duragen duraplasty and Duraguard duraplasty in people with Chiari Malformation, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chiari Malformation
- What is being tested?
- Duragen duraplasty and Duraguard duraplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Apr 2010
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic Chiari malformation
Who cannot join
- Presence of ventriculoperitoneal shunt
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Medical Center in Chicago
Chicago, Illinois, 60612
About this study
Official title: Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.
Read the detailed description
The study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. Both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. This study follows patients with Chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.
- Conditions
- Chiari Malformation
- Being tested
- Duragen duraplasty, Duraguard duraplasty
- Keywords
- Chiari malformation;, Duraplasty;, Posterior fossa decompression;, Duragen;, Duraguard
- Medical subject headings
- Arnold-Chiari Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duragen duraplastyProcedure or surgery
Also called Duragen (Arm 1; active comparator)
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
Duraguard duraplastyProcedure or surgery
Also called Duraguard (Arm 2; active comparator)
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
| Study group | Role | What they receive |
|---|---|---|
| DuraGen (sutureless) | Experimental | Duragen duraplasty - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual. Receives: Procedure: Duragen duraplasty |
| DuraGuard (suturable) | Active comparator | Duraguard duraplasty - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure. Receives: Procedure: Duraguard duraplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Health Quality of Life
Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startApr 2003
- Primary completionDec 2009
- Study completionApr 2010
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 Chiari MalformationStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantin V. Slavin, University of Illinois Chicago
- Investigators
- Konstantin V Slavin, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741858
- Sponsor's protocol ID
- UIC 2002-0232
- Status last verified
- Jul 2015
- First submitted
- 25 Aug 2008
- Last updated
- 13 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
- ClinicalTrials.gov ID
- NCT00741858
- Acronym / sponsor ID
- UIC 2002-0232
- Conditions
- Chiari Malformation
- Keywords
- Chiari malformation;, Duraplasty;, Posterior fossa decompression;, Duragen;, Duraguard
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Posted 13 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.
Detailed description
The study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. Both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. This study follows patients with Chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuraGen (sutureless) | Experimental | Procedure: Duragen duraplastyDuragen duraplasty - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual. |
| DuraGuard (suturable) | Active comparator | Procedure: Duraguard duraplastyDuraguard duraplasty - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic Chiari malformation
Key exclusion criteria (2 listed)
- Presence of ventriculoperitoneal shunt
- Pregnancy
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 |
|---|---|---|
| Duragen duraplastyAlso: Duragen (Arm 1; active comparator)Posterior cranial fossa repair and enlargement with application of dural patch (Duragen) | Procedure or surgery | DuraGen (sutureless) |
| Duraguard duraplastyAlso: Duraguard (Arm 2; active comparator)Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard) | Procedure or surgery | DuraGuard (suturable) |
Primary outcome
Physical Health Quality of Life
Time frame: 7 years
Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Departmental websiteLink 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.
Konstantin V Slavin, MD principal investigator
University of Illinois Chicago
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 Duragen duraplasty and Duraguard duraplasty in people with Chiari Malformation, run by University of Illinois Chicago 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 2 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 13 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2015). 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?
Physical Health Quality of Life (time frame: 7 years). 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 13 Jul 2015.