Skip to main content
OpenTrials
Completed

NCT Number: NCT02594137

A Comparison Between Two Techniques for Performing Decompressive Craniectomy

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).

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Without watertight duraplasty

Procedure

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.

Primary outcomes

  1. Surgical Complications

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

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

Secondary outcomes

  1. Clinical Outcome (Analyzed by the Glasgow Outcome Scale)

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

  2. Hospital Costs

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

  3. Surgical Time

    Time frame: From skin incision until closure is completed (maximum of 4 hours)

Sponsors and collaborators

Lead sponsor

Hospital of the Restoration, Recife

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 2, 2015
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.