The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair. Specifically this study compares craniectomy without dHACM application to craniectomy with placement of dHACM between the galea and dura over dural suture line and/or exposed parenchyma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
7
A piece of dHACM placed over any dural defect or dural closure during craniectomy.
Removal of the skull flap followed by closure techniques per current SOC.
Boulder Neurological Associates
Boulder, Colorado, United States
Chattanooga Center for Neurological Research
Chattanooga, Tennessee, United States
Degree of scarring between the galea and the dura, as assessed by the Ease of Dissection (EOD) Score and histological analysis upon reoperation in patients receiving craniectomy with durotomy.
Time frame: 6 Months
Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.
Time frame: 6 Months
Post-operative complications at original and re-operation
Time frame: 6 Months
Peri-operative measures at original and re-operation
Time frame: 6 Months
Survival
Time frame: 6 Months
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