Brain Edema, Craniocerebral Trauma, Infarction, Middle Cerebral Artery
Conditions
Keywords
Decompressive craniectomy, Brain Edema
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).
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.
Interventions
PROCEDUREWithout 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.
Sponsors
Hospital of the Restoration, Recife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications | From surgical procedure until hospital discharge or death (maximum of 90 days) | Cerebrospinal Fluid Leaks, Wound Infection, Brain Abscess, Subgaleal Fluid Collections) |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Outcome (Analyzed by the Glasgow Outcome Scale) | From surgical procedure until hospital discharge or death (maximum of 90 days) |
| Hospital Costs | From surgical procedure until hospital discharge or death (maximum of 90 days) |
| Surgical Time | From skin incision until closure is completed (maximum of 4 hours) |
Outcome results
None listed