Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies (ViaShield)
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|ClinicalTrials.gov Identifier: NCT03371316|
Recruitment Status : Withdrawn (Site is no longer participating in study)
First Posted : December 13, 2017
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hemicraniectomies||Biological: ViaShield||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients requiring a hemicraniectomy will also receive the amnion patch as an anti-adhesive barrier|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies|
|Actual Study Start Date :||January 20, 2018|
|Actual Primary Completion Date :||January 30, 2018|
|Actual Study Completion Date :||January 30, 2018|
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
- Adhesion [ Time Frame: 4-8 months ]
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
- Infections [ Time Frame: From time of surgery to 8 months post-operative ]Wound Infections in or around hemicraniectomy site
- hydrocephalus [ Time Frame: From time of surgery to 8 months post-operative ]Accumulation of fluid around the brain