A Comparison Between Two Techniques for Performing Decompressive Craniectomy

Hospital of the Restoration, Recife

Status: Completed

Conditions: Infarction, Middle Cerebral Artery; Brain Edema; Craniocerebral Trauma

Treatments: Procedure: Without watertight duraplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02594137

0115.0.102.000-11

Details and patient eligibility

About

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).

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Without Watertight Duraplasty

Experimental group

Description:

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.

Treatment:

Procedure: Without watertight duraplasty

With Watertight Duraplasty

No Intervention group

Description:

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.