A Comparison Between Two Techniques for Performing Decompressive Craniectomy

Hospital of the Restoration, Recife58 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Brain Edema Craniocerebral Trauma Infarction, Middle Cerebral Artery

Interventions

Without watertight duraplastyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Surgical Complications

Cerebrospinal Fluid Leaks, Wound Infection, Brain Abscess, Subgaleal Fluid Collections)

Time frame: From surgical procedure until hospital discharge or death (maximum of 90 days)

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)

Data from ClinicalTrials.gov

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