A Comparison Between Two Techniques for Performing Decompressive Craniectomy

October 30, 2015 updated by: Eduardo Vieira de Carvalho Junior, Hospital of the Restoration, Recife

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
NO_INTERVENTION: With Watertight Duraplasty
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From surgical procedure until hospital discharge or death (maximum of 90 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Outcome (Analyzed by the Glasgow Outcome Scale)
Time Frame: From surgical procedure until hospital discharge or death (maximum of 90 days)
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)
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)
From skin incision until closure is completed (maximum of 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital of the Restoration, Recife

Investigators

  • Principal Investigator: Eduardo V Carvalho Junior, MD, Hospital of the Restoration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (ESTIMATE)

November 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0115.0.102.000-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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