Brain EdemaNCT02594137
A Comparison Between Two Techniques for Performing Decompressive Craniectomy
A study testing Without watertight duraplasty in people with Brain Edema and Craniocerebral Trauma, run by Hospital of the Restoration, Recife.
Trial summary
The purpose of this study is to compare two surgical techniques for a neurosurgical procedure used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Edema, Craniocerebral Trauma, Infarction, Middle Cerebral Artery
- What is being tested?
- Without watertight duraplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients admitted to the Neurotrauma Service of the Hospital of Restoration from January 2012 to December 2013, age range 18 to 60 years old and with clinical indication for decompressive craniectomy.
Who cannot join
- Indication for bifrontal decompressive craniectomy.
- Indication for Posterior Fossa decompressive craniectomy
- Patients with intra-axial contusions or hematomas requiring surgical evacuation in which case injury to the arachnoid could lead to an increased risk of cerebrospinal fluid leak
About this study
Official title: A Randomized Controlled Study Comparing 2 Surgical Techniques for Decompressive Craniectomy: With Watertight Duraplasty Versus Without Watertight Duraplasty.
The purpose of this study is to compare two surgical techniques for a neurosurgical procedure used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy).
Read the detailed description
After clinical indication for unilateral decompressive craniectomy (DC), patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) vs. without watertight duraplasty / rapid closure DC (test group). In all cases, a large trauma flap (i.e. large reverse question mark starting from the tragus and extending to the midline) was performed. Skin, galea and muscle layers were elevated according to surgeon preference. Thus a wide (at least 12x15cm) craniotomy was performed and the temporal bone was removed until flush with the middle fossa floor. After dural opening, watertight duraplasty with pericranium or an artificial graft (at surgeon's discretion) was performed in the control group, while no watertight duraplasty was performed in the test group, and exposed brain parenchyma was covered with Surgicel®. Usual closure was then performed. Patients were then monitored daily by evaluators blinded to the randomization (control or test group) from the date of surgery until hospital discharge or death.
- Being tested
- Without watertight duraplasty
- Keywords
- Decompressive craniectomy, Brain Edema
- Medical subject headings
- Brain Edema, Craniocerebral Trauma, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without watertight duraplastyProcedure or surgery
After standard craniectomy and dural opening, provided there is no brain contusions or hematomas requiring surgical evacuation, no watertight duraplasty is performed. The dura is left opened and the brain parenchyma is covered with Surgicel. Usual closure is then performed.
| Study group | Role | What they receive |
|---|---|---|
| Without Watertight Duraplasty | Experimental | After standard craniectomy (12x15cm) and dural opening, the "intervention", which is to not perform watertight duraplasty is carried out. The exposed brain parenchyma is covered with Surgicel. Usual closure is then performed. Receives: Procedure: Without watertight duraplasty |
| With Watertight Duraplasty | No intervention | After standard craniectomy (12x15cm) and dural opening, watertight duraplasty with pericranium or an artificial graft is performed. Usual closure is then performed. This kind of duraplasty is performed by most neurosurgeons and this group will be used as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Complications
Cerebrospinal Fluid Leaks, Wound Infection, Brain Abscess, Subgaleal Fluid Collections)
Measured: From surgical procedure until hospital discharge or death (maximum of 90 days)
Secondary outcomes (3)
Clinical Outcome (Analyzed by the Glasgow Outcome Scale)
Measured: From surgical procedure until hospital discharge or death (maximum of 90 days)
Hospital Costs
Measured: From surgical procedure until hospital discharge or death (maximum of 90 days)
Surgical Time
Measured: From skin incision until closure is completed (maximum of 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain EdemaStudies 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
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital of the Restoration, Recife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Vieira de Carvalho Junior, Hospital of the Restoration, Recife
- Investigators
- Eduardo V Carvalho Junior, MD, Principal investigator, Hospital of the Restoration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594137
- Sponsor's protocol ID
- 0115.0.102.000-11
- Status last verified
- Oct 2015
- First submitted
- 29 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guresir E, Vatter H, Schuss P, Oszvald A, Raabe A, Seifert V, Beck J. Rapid closure technique in decompressive craniectomy. J Neurosurg. 2011 Apr;114(4):954-60. doi: 10.3171/2009.12.JNS091065. Epub 2010 Jan 29.
PubMed 20113157Barth M, Tuettenberg J, Thome C, Weiss C, Vajkoczy P, Schmiedek P. Watertight dural closure: is it necessary? A prospective randomized trial in patients with supratentorial craniotomies. Neurosurgery. 2008 Oct;63(4 Suppl 2):352-8; discussion 358. doi: 10.1227/01.NEU.0000310696.52302.99.
PubMed 18981842Sade B, Oya S, Lee JH. Non-watertight dural reconstruction in meningioma surgery: results in 439 consecutive patients and a review of the literature. Clinical article. J Neurosurg. 2011 Mar;114(3):714-8. doi: 10.3171/2010.7.JNS10460. Epub 2010 Aug 13.
PubMed 20707618Ragel BT, Klimo P Jr, Martin JE, Teff RJ, Bakken HE, Armonda RA. Wartime decompressive craniectomy: technique and lessons learned. Neurosurg Focus. 2010 May;28(5):E2. doi: 10.3171/2010.3.FOCUS1028.
PubMed 20568936Kolias AG, Kirkpatrick PJ, Hutchinson PJ. Decompressive craniectomy: past, present and future. Nat Rev Neurol. 2013 Jul;9(7):405-15. doi: 10.1038/nrneurol.2013.106. Epub 2013 Jun 11.
PubMed 23752906Vieira E, Guimaraes TC, Faquini IV, Silva JL, Saboia T, Andrade RVCL, Gemir TL, Neri VC, Almeida NS, Azevedo-Filho HRC. Randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty. J Neurosurg. 2018 Oct;129(4):1017-1023. doi: 10.3171/2017.4.JNS152954. Epub 2017 Nov 17.
PubMed 29148904
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing 2 Surgical Techniques for Decompressive Craniectomy: With Watertight Duraplasty Versus Without Watertight Duraplasty.
- ClinicalTrials.gov ID
- NCT02594137
- Acronym / sponsor ID
- 0115.0.102.000-11
- Keywords
- Decompressive craniectomy, Brain Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital of the Restoration, RecifeUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Nov 2015 (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 purpose of this study is to compare two surgical techniques for a neurosurgical procedure used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy).
Detailed description
After clinical indication for unilateral decompressive craniectomy (DC), patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) vs. without watertight duraplasty / rapid closure DC (test group). In all cases, a large trauma flap (i.e. large reverse question mark starting from the tragus and extending to the midline) was performed. Skin, galea and muscle layers were elevated according to surgeon preference. Thus a wide (at least 12x15cm) craniotomy was performed and the temporal bone was removed until flush with the middle fossa floor. After dural opening, watertight duraplasty with pericranium or an artificial graft (at surgeon's discretion) was performed in the control group, while no watertight duraplasty was performed in the test group, and exposed brain parenchyma was covered with Surgicel®. Usual closure was then performed. Patients were then monitored daily by evaluators blinded to the randomization (control or test group) from the date of surgery until hospital discharge or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Watertight Duraplasty | Experimental | Procedure: Without watertight duraplastyAfter standard craniectomy (12x15cm) and dural opening, the "intervention", which is to not perform watertight duraplasty is carried out. The exposed brain parenchyma is covered with Surgicel. Usual closure is then performed. |
| With Watertight Duraplasty | No intervention | –After standard craniectomy (12x15cm) and dural opening, watertight duraplasty with pericranium or an artificial graft is performed. Usual closure is then performed. This kind of duraplasty is performed by most neurosurgeons and this group will be used as a control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients admitted to the Neurotrauma Service of the Hospital of Restoration from January 2012 to December 2013, age range 18 to 60 years old and with clinical indication for decompressive craniectomy.
Key exclusion criteria (3 listed)
- Indication for bifrontal decompressive craniectomy.
- Indication for Posterior Fossa decompressive craniectomy
- Patients with intra-axial contusions or hematomas requiring surgical evacuation in which case injury to the arachnoid could lead to an increased risk of cerebrospinal fluid leak
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 |
|---|---|---|
| Without watertight duraplastyAfter standard craniectomy and dural opening, provided there is no brain contusions or hematomas requiring surgical evacuation, no watertight duraplasty is performed. The dura is left opened and the brain parenchyma is covered with Surgicel. Usual closure is then performed. | Procedure or surgery | Without Watertight Duraplasty |
Primary outcome
Surgical Complications
Time frame: From surgical procedure until hospital discharge or death (maximum of 90 days)
Cerebrospinal Fluid Leaks, Wound Infection, Brain Abscess, Subgaleal Fluid Collections)
3 secondary outcomes
Clinical Outcome (Analyzed by the Glasgow Outcome Scale)
Time frame: From surgical procedure until hospital discharge or death (maximum of 90 days)
Hospital Costs
Time frame: From surgical procedure until hospital discharge or death (maximum of 90 days)
Surgical Time
Time frame: From skin incision until closure is completed (maximum of 4 hours)
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 2 Nov 2015.
- Background: PubMed 20113157Guresir E, Vatter H, Schuss P, Oszvald A, Raabe A, Seifert V, Beck J. Rapid closure technique in decompressive craniectomy. J Neurosurg. 2011 Apr;114(4):954-60. doi: 10.3171/2009.12.JNS091065. Epub 2010 Jan 29.
- Background: PubMed 18981842Barth M, Tuettenberg J, Thome C, Weiss C, Vajkoczy P, Schmiedek P. Watertight dural closure: is it necessary? A prospective randomized trial in patients with supratentorial craniotomies. Neurosurgery. 2008 Oct;63(4 Suppl 2):352-8; discussion 358. doi: 10.1227/01.NEU.0000310696.52302.99.
- Background: PubMed 20707618Sade B, Oya S, Lee JH. Non-watertight dural reconstruction in meningioma surgery: results in 439 consecutive patients and a review of the literature. Clinical article. J Neurosurg. 2011 Mar;114(3):714-8. doi: 10.3171/2010.7.JNS10460. Epub 2010 Aug 13.
- Background: PubMed 20568936Ragel BT, Klimo P Jr, Martin JE, Teff RJ, Bakken HE, Armonda RA. Wartime decompressive craniectomy: technique and lessons learned. Neurosurg Focus. 2010 May;28(5):E2. doi: 10.3171/2010.3.FOCUS1028.
- Background: PubMed 23752906Kolias AG, Kirkpatrick PJ, Hutchinson PJ. Decompressive craniectomy: past, present and future. Nat Rev Neurol. 2013 Jul;9(7):405-15. doi: 10.1038/nrneurol.2013.106. Epub 2013 Jun 11.
- Derived from this study: PubMed 29148904Vieira E, Guimaraes TC, Faquini IV, Silva JL, Saboia T, Andrade RVCL, Gemir TL, Neri VC, Almeida NS, Azevedo-Filho HRC. Randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty. J Neurosurg. 2018 Oct;129(4):1017-1023. doi: 10.3171/2017.4.JNS152954. Epub 2017 Nov 17.
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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.
Eduardo V Carvalho Junior, MD principal investigator
Hospital of the Restoration
Questions about this trial
What is this clinical trial studying?
A study testing Without watertight duraplasty in people with Brain Edema and Craniocerebral Trauma, run by Hospital of the Restoration, Recife.
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 3 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Surgical Complications (time frame: From surgical procedure until hospital discharge or death (maximum of 90 days)). 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 NCT02594137, which also lists 6 linked publications.
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 2 Nov 2015.