Cranial Dura RepairNCT00859508
Study of SyntheCelTM Dura Replacement to Other Dura Replacements
A study testing SyntheCel and Other FDA cleared dura replacements in people with Cranial Dura Repair, run by Synthes USA HQ, Inc. at 8 sites in United States.
Trial summary
Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cranial Dura Repair
- What is being tested?
- SyntheCel and Other FDA cleared dura replacements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2006to Jan 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 requiring a dural incision
- Patient has an MRI no earlier than two months prior to the date of enrollment
- Surgical wound is expected to be Class I/clean
- Patient is available and willing to participate in the investigation for the duration of the study
- Patient has signed a written Informed Consent to participate in the study prior to any study mandated determinations or procedures. This does not include MRIs that may be performed prior to obtaining informed consent.
Who cannot join
- Patient has a cranial metallic implant(s) that would interfere with evaluation of the device or recovery
- Patient is somnolent or comatose (Glasgow score< 8)
- Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
- Patient will require use of a dural adhesive or sealant
- Patient has known hydrocephalus
- Patient's life expectancy is less than 6 months
Show all 19Show fewer
- Patient has a systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 101°F, positive blood culture and/or a positive chest x-ray for acute infectious process
- Patient has known allergy to device component (cellulose)
- Patient is an acute cranial trauma surgical case
- Patient has a local cranial infection
- Patient has had chemotherapy and/or radiation treatment within 12 weeks prior to surgery, or has chemotherapy and/or radiation treatment planned 10 weeks post surgery
- Patient has been clinically diagnosed with malignancy (other than basal cell carcinoma or low grade glioma), uncontrolled diabetes, sepsis, systemic collagen disease
- Patient has creatinine levels > 2.0 mg/dL
- Patient has total bilirubin level > 2.5 mg/dL
- Patent has clinically significant coagulopathy with a partial thromboplastin time (PTT) ≥ 35, international normalized ratio (INR) ≥ 1.2, or is receiving Warfarin or Coumadin
- Patient has a compromised immune system or autoimmune disease (white blood cell (WBC) count <4000/uL or >20,000/uL)
- Patient is participating in another clinical trial using investigational devices/drugs
- Patient is pregnant or breastfeeding or wishes to become pregnant during the course of the study
- Patient is unable or unwilling to sign a consent form
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Virginia
Charlottesville, Virginia, 22903
University of Florida
Gainesville, Florida, 32611
University of Texas
Houston, Texas, 77030
West Virginia University School of Medicine
Morgantown, West Virginia, 26506
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health Sciences University
Portland, Oregon, 97239
Barrow Neurosurgical Institute
Scottsdale, Arizona, 85251
Stanford Medical Center
Stanford, California, 94305
About this study
Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery
Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.
- Conditions
- Cranial Dura Repair
- Being tested
- SyntheCel, Other FDA cleared dura replacements
- Keywords
- dura repair following cranial surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntheCelDevice
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
Other FDA cleared dura replacementsDevice
Also called Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, Durepair Dura regeneration Matrix
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
| Study group | Role | What they receive |
|---|---|---|
| SyntheCel | Experimental | Not described Receives: Device: SyntheCel |
| other FDA cleared dura replacements | Active comparator | Not described Receives: Device: Other FDA cleared dura replacements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
Measured: 6 months
Secondary outcomes (5)
Modified Rankin Scale (Patient Function Assessment)
Measured: up to 6 months
Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
Measured: up to 6 months
Wound Healing Assessment
Measured: up to 6 months
Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
Measured: up to 6 months
Radiographic Evaluation
Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)
- Adhesion formation
- Membrane formation
- Abnormal thickening along graft (device implant) site
- Brain edema adjacent to graft (device implant) site
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startFeb 2006
- Primary completionJan 2009
- Study completionJan 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 Cranial Dura RepairStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes USA HQ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859508
- Sponsor's protocol ID
- SyntheCel
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2009
- Last updated
- 8 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Rosen CL, Steinberg GK, DeMonte F, Delashaw JB Jr, Lewis SB, Shaffrey ME, Aziz K, Hantel J, Marciano FF. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. doi: 10.1227/NEU.0b013e3182284aca.
PubMed 21670715
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery
- ClinicalTrials.gov ID
- NCT00859508
- Acronym / sponsor ID
- SyntheCel
- Conditions
- Cranial Dura Repair
- Keywords
- dura repair following cranial surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 6 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SyntheCel | Experimental | Device: SyntheCel |
| other FDA cleared dura replacements | Active comparator | Device: Other FDA cleared dura replacements |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is between 18 and 75 years of age
- Patient is scheduled for an elective cranial procedure requiring a dural incision
- Patient has an MRI no earlier than two months prior to the date of enrollment
- Surgical wound is expected to be Class I/clean
- Patient is available and willing to participate in the investigation for the duration of the study
Key exclusion criteria (19 listed)
- Patient has a cranial metallic implant(s) that would interfere with evaluation of the device or recovery
- Patient is somnolent or comatose (Glasgow score< 8)
- Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
- Patient will require use of a dural adhesive or sealant
- Patient has known hydrocephalus
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 |
|---|---|---|
| SyntheCelPatients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement. | Device | SyntheCel |
| Other FDA cleared dura replacementsAlso: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, Durepair Dura regeneration MatrixPatients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement. | Device | other FDA cleared dura replacements |
Primary outcome
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
Time frame: 6 months
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
5 secondary outcomes
Modified Rankin Scale (Patient Function Assessment)
Time frame: up to 6 months
Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
Time frame: up to 6 months
Wound Healing Assessment
Time frame: up to 6 months
Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
Time frame: up to 6 months
Radiographic Evaluation
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21670715Rosen CL, Steinberg GK, DeMonte F, Delashaw JB Jr, Lewis SB, Shaffrey ME, Aziz K, Hantel J, Marciano FF. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. doi: 10.1227/NEU.0b013e3182284aca.
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyntheCel and Other FDA cleared dura replacements in people with Cranial Dura Repair, run by Synthes USA HQ, Inc. at 8 sites 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 6 inclusion and 19 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 6 Mar 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?
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele (time frame: 6 months). 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 NCT00859508, 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 8 Mar 2012.