Craniocerebral Trauma Clinical Trial
Official title:
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).
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04741334 -
Mild Head Injury, Antiplatelets, and Anticoagulants
|
||
| Terminated |
NCT01430988 -
Observational Study of the BrainScope® Ahead™ M-100 in UK Emergency Department Patients With Head Injury
|
N/A | |
| Completed |
NCT00860210 -
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
|
Phase 1 | |
| Completed |
NCT00409058 -
Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI
|
N/A | |
| Completed |
NCT00251108 -
Fitness Training After Traumatic Brain Injury
|
N/A | |
| Completed |
NCT02881957 -
Hypovitaminosis D in Neurocritical Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT02368366 -
Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
|
N/A | |
| Completed |
NCT02819778 -
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
|
N/A | |
| Completed |
NCT01886222 -
Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury
|
N/A | |
| Recruiting |
NCT06015451 -
Exercise in Postconcussion Symptoms and Posttraumatic Headache
|
N/A | |
| Completed |
NCT03314480 -
REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury
|
||
| Completed |
NCT05292690 -
An Assistive Powered Wheelchair: Stage 2 Trial
|
||
| Terminated |
NCT01961804 -
PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
|
Phase 3 | |
| Completed |
NCT00005004 -
Brain Processing of Language Meanings
|
N/A | |
| Recruiting |
NCT05306951 -
Correct Timing of Head Imaging in Trauma
|
||
| Completed |
NCT05891522 -
Pilot Study of the Use of a Portable Cranial Scanner in Intensive Care for Cerebro-injured Patients
|
N/A | |
| Completed |
NCT02776462 -
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
|
||
| Completed |
NCT00200135 -
Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law
|
N/A | |
| Completed |
NCT00534157 -
Study of Eye Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population
|
N/A | |
| Recruiting |
NCT01633268 -
Estimating Brain Biomechanics Using MRI
|