Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies (ViaShield)
Study Overview
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
18 years of age minimum Informed consent signed by patient or next of kin
Exclusion Criteria:
Immunosuppressive disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hemicraniectomy Surgery with Viashield
All patients requiring a hemicraniectomy surgery will receive the anti-adhesion barrier of amnion patch.
|
Anti-adhesion scores using amnion patch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adhesion
Time Frame: 4-8 months
|
Adhesion tenacity scores post hemicraniectomies 0 No adhesions
|
4-8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infections
Time Frame: From time of surgery to 8 months post-operative
|
Wound Infections in or around hemicraniectomy site
|
From time of surgery to 8 months post-operative
|
|
hydrocephalus
Time Frame: From time of surgery to 8 months post-operative
|
Accumulation of fluid around the brain
|
From time of surgery to 8 months post-operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RGC17-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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