Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies

Conditions
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Hemicraniectomies

Intervention / Treatment
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* Biological: ViaShield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age minimum Informed consent signed by patient or next of kin Exclusion Criteria: Immunosuppressive disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients requiring a hemicraniectomy will also receive the amnion patch as an anti-adhesive barrier
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemicraniectomy Surgery with Viashield<br>All patients requiring a hemicraniectomy surgery will receive the anti-adhesion barrier of amnion patch. | Biological: ViaShield<br>* Anti-adhesion scores using amnion patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion | Adhesion tenacity scores post hemicraniectomies 0 No adhesions Thin membranous adhesions, no vessel attachment Mild adhesions, blunt dissection required Moderate adhesions, some sharp dissection required Tenacious adhesions, sharp instrument dissection required, vessels attached The lower the score the better the outcome for the patient | 4-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections | Wound Infections in or around hemicraniectomy site | From time of surgery to 8 months post-operative | 
| hydrocephalus | Accumulation of fluid around the brain | From time of surgery to 8 months post-operative |