NCT02594137

A Comparison Between Two Techniques for Performing Decompressive Craniectomy

A Randomized Controlled Study Comparing 2 Surgical Techniques for Decompressive Craniectomy: With Watertight Duraplasty Versus Without Watertight Duraplasty.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Hospital of the Restoration, Recife · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Edema
• Craniocerebral Trauma
• Infarction, Middle Cerebral Artery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2015-11-02
• Last updated: 2015-11-02