Clinical Trial: A Comparison Between Two Techniques for Performing Decompressive Craniectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Hospital of the Restoration, Recife

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Outcome (Analyzed by the Glasgow Outcome Scale) [ Time Frame: 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) ]
  • Surgical Time [ Time Frame: From skin incision until closure is completed (maximum of 4 hours) ]


Original Secondary Outcome: Same as current

Information By: Hospital of the Restoration, Recife

Dates:
Date Received: October 29, 2015
Date Started: January 2012
Date Completion:
Last Updated: October 30, 2015
Last Verified: October 2015