Dura DefectsPhase 2/3NCT01174992
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
A Phase 2/3 study testing Evicel and Sutures only in people with Dura Defects, run by Ethicon, Inc. at 12 sites in 6 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dura Defects
- What is being tested?
- Evicel and Sutures only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 12 sitesin 6 countries
- Study dates
- Jul 2010to Oct 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective craniotomy/craniectomy
- Age greater than or equal to 18 years
- Patients who are able and willing to comply with the procedures required by the protocol.
- Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.
Who cannot join
- Chemotherapy or radiation therapy within 7 days following surgery.
- Conditions compromising the immune system.
- Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
- Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
- Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
- Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.
- Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Germany4 sites
Klinik für Neurochirurgie, Universitätsklinikum Essen
Essen, D-45122
Department of Neurosurgery, University Giessen-Marburg
Giessen, 35385
Department of Neurosurgery, Klinikum Ingolstadt GmbH
Ingolstadt, 85049
Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel
Kiel, D-24105
United Kingdom3 sites
Department of Neurosurgery, Ninewells Hospital & Medical School
Dundee, DD1 9SY
Edinburgh Centre for Neuro-Oncology, Western General Hospital
Edinburgh, EH4 2XU
Department of Neurosurgery, John Radcliffe Hospital
Headington, Oxford, OX3 9DU
Belgium2 sites
Department of Neurosurgery, Ziekenhuis Oost Limburg
Genk, B-3600
Department of Neurosurgery, University Hospital of Liège
Liège, B-4000
Finland1 site
Department of Neurosciences and Rehabilitation, Tampere University Hospital
Tampere, FI-33521
France1 site
Service de Neurochirurgie B, Hopital Neurologique de Lyon
Cedex, 696 BRON
About this study
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
Read the detailed description
This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
- Conditions
- Dura Defects
- Being tested
- Evicel, Sutures only
- Keywords
- Fibrin sealant, CSF leak
- Medical subject headings
- Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvicelBiological
EVICEL is a human plasma derived fibrin sealant
Sutures onlyOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Evicel | Experimental | Not described Receives: Biological: Evicel |
| Sutures only | Other | Not described Receives: Other: Sutures only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of success
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.
Measured: Day 1 (intraoperative)
Secondary outcomes (4)
Incidence of CSF leakage
Measured: Day 5 post-op
Incidence of CSF leakage
Measured: Day 30 post-op
Incidence of adverse events
Measured: up to 30 days post-op
Incidence of surgical site infections
Measured: Day 5 and 30 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dura DefectsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Responsible party
- Sponsor
- Investigators
- James Hart, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174992
- Sponsor's protocol ID
- 400-09-001
- Other IDs
- 2009-016501-41, 2009
- Status last verified
- Jun 2012
- First submitted
- 3 Aug 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
- ClinicalTrials.gov ID
- NCT01174992
- Acronym / sponsor ID
- 400-09-001
- Conditions
- Dura Defects
- Keywords
- Fibrin sealant, CSF leak
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OMRIX Biopharmaceuticals
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 Aug 2010 (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.
The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
Detailed description
This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evicel | Experimental | Biological: Evicel |
| Sutures only | Other | Other: Sutures only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective craniotomy/craniectomy
- Age greater than or equal to 18 years
- Patients who are able and willing to comply with the procedures required by the protocol.
- Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.
Key exclusion criteria (7 listed)
- Chemotherapy or radiation therapy within 7 days following surgery.
- Conditions compromising the immune system.
- Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
- Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
- Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
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 |
|---|---|---|
| EvicelEVICEL is a human plasma derived fibrin sealant | Biological | Evicel |
| Sutures onlyStandard of care | Other | Sutures only |
Primary outcome
Proportion of success
Time frame: Day 1 (intraoperative)
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.
4 secondary outcomes
Incidence of CSF leakage
Time frame: Day 5 post-op
Incidence of CSF leakage
Time frame: Day 30 post-op
Incidence of adverse events
Time frame: up to 30 days post-op
Incidence of surgical site infections
Time frame: Day 5 and 30 post-op
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 20 Jun 2012.
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.
James Hart, MD study director
Ethicon, Inc.
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Evicel and Sutures only in people with Dura Defects, run by Ethicon, Inc. at 12 sites in 6 countries.
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 4 inclusion and 7 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 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, United Kingdom, Belgium, Finland, France and 1 more country. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of success (time frame: Day 1 (intraoperative)). 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 20 Jun 2012.