Hemicraniectomies
Conditions
Brief summary
The goal of this study is to demonstrate that ViaShield™ amnion patch is effective in preventing fibroblast activity and hence soft tissue adhesions after a hemicraniectomy.
Detailed description
A hemicraniectomy is a surgical procedure in which part of the skull is temporarily removed to relieve pressure on the underlying brain. Hemicraniectomies are typically performed on patients experiencing severe brain injury, usually due to stroke or trauma. In these cases, the brain injury and swelling is so severe that it can lead to brain compression and brain death. As a result, a surgeon will remove the bone flap to help with brain swelling and increased intracranial pressure. After the patient heals, a cranioplasty will be performed to restore the bone flap to its original location. When the central nervous system is deprived of its normal covering, as is the case with hemicraniectomies, the exposed area becomes the site of cellular reaction from surrounding tissue1 and soft tissue adhesions frequently develop between the skin flap and the dura mater or exposed brain, which may lead to less than optimal clinical outcome. ViaShield™ is an amnion patch produced from human amniotic membrane. Because of its inherent anti-adhesive properties, amnion serves as an ideal barrier against scarring and soft tissue adhesions to the neural elements, anterior vessels and hardware.
Interventions
BIOLOGICALViaShield
Anti-adhesion scores using amnion patch
Sponsors
Globus Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients requiring a hemicraniectomy will also receive the amnion patch as an anti-adhesive barrier
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years of age minimum Informed consent signed by patient or next of kin
Exclusion criteria
Immunosuppressive disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion | 4-8 months | Adhesion tenacity scores post hemicraniectomies 0 No adhesions 1. Thin membranous adhesions, no vessel attachment 2. Mild adhesions, blunt dissection required 3. Moderate adhesions, some sharp dissection required 4. Tenacious adhesions, sharp instrument dissection required, vessels attached The lower the score the better the outcome for the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infections | From time of surgery to 8 months post-operative | Wound Infections in or around hemicraniectomy site |
| hydrocephalus | From time of surgery to 8 months post-operative | Accumulation of fluid around the brain |
Outcome results
None listed