A Comparison Between Two Techniques for Performing Decompressive Craniectomy
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|ClinicalTrials.gov Identifier: NCT02594137|
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Brain Edema Craniocerebral Trauma Infarction, Middle Cerebral Artery||Procedure: Without watertight duraplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Study Comparing 2 Surgical Techniques for Decompressive Craniectomy: With Watertight Duraplasty Versus Without Watertight Duraplasty.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
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.
- 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)
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594137
|Principal Investigator:||Eduardo V Carvalho Junior, MD||Hospital of the Restoration|