A Comparison Between Two Techniques for Performing Decompressive Craniectomy

Not Applicable

Completed

• Conditions: Brain Edema; Craniocerebral Trauma; Infarction, Middle Cerebral Artery
• Interventions: Procedure: Without watertight duraplasty

• Registration Number: NCT02594137
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2015-10
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Study First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Watertight Duraplasty	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hospital Costs	From surgical procedure until hospital discharge or death (maximum of 90 days)
Clinical Outcome (Analyzed by the Glasgow Outcome Scale)	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)