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A Comparison Between Two Techniques for Performing Decompressive Craniectomy

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ClinicalTrials.gov Identifier: NCT02594137
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Eduardo Vieira de Carvalho Junior, Hospital of the Restoration, Recife

Brief 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).

Condition or disease Intervention/treatment Phase
Brain Edema Craniocerebral Trauma Infarction, Middle Cerebral Artery Procedure: Without watertight duraplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Comparing 2 Surgical Techniques for Decompressive Craniectomy: With Watertight Duraplasty Versus Without Watertight Duraplasty.
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Without Watertight Duraplasty
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.
Procedure: Without watertight duraplasty
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.

No Intervention: With Watertight Duraplasty
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Clinical Outcome (Analyzed by the Glasgow Outcome Scale) [ Time Frame: From surgical procedure until hospital discharge or death (maximum of 90 days) ]
  2. Hospital Costs [ Time Frame: From surgical procedure until hospital discharge or death (maximum of 90 days) ]
  3. Surgical Time [ Time Frame: From skin incision until closure is completed (maximum of 4 hours) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594137


Sponsors and Collaborators
Hospital of the Restoration, Recife
Investigators
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Principal Investigator: Eduardo V Carvalho Junior, MD Hospital of the Restoration

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eduardo Vieira de Carvalho Junior, Professor in Residence of Neurological Surgery, Hospital of the Restoration, Recife
ClinicalTrials.gov Identifier: NCT02594137     History of Changes
Other Study ID Numbers: 0115.0.102.000-11
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Eduardo Vieira de Carvalho Junior, Hospital of the Restoration, Recife:
Decompressive craniectomy
Brain Edema

Additional relevant MeSH terms:
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Infarction
Brain Edema
Craniocerebral Trauma
Infarction, Middle Cerebral Artery
Ischemia
Pathologic Processes
Necrosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases