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A Comparison Between Two Techniques for Performing Decompressive Craniectomy

NCT02594137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-11-02

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospital of the Restoration, Recife

    lead OTHER

Principal Investigators

  • Eduardo V Carvalho Junior, MD · Hospital of the Restoration

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2014-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594137 on ClinicalTrials.gov