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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03371316
Recruitment Status : Withdrawn (Site is no longer participating in study)
First Posted : December 13, 2017
Last Update Posted : February 15, 2018
Information provided by (Responsible Party):
Globus Medical Inc

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.

Condition or disease Intervention/treatment Phase
Hemicraniectomies Biological: ViaShield Not Applicable

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.

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Hemicraniectomy Surgery with Viashield
All patients requiring a hemicraniectomy surgery will receive the anti-adhesion barrier of amnion patch.
Biological: ViaShield
Anti-adhesion scores using amnion patch

Primary Outcome Measures :
  1. Adhesion [ Time Frame: 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 Outcome Measures :
  1. Infections [ Time Frame: From time of surgery to 8 months post-operative ]
    Wound Infections in or around hemicraniectomy site

  2. hydrocephalus [ Time Frame: From time of surgery to 8 months post-operative ]
    Accumulation of fluid around the brain

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

18 years of age minimum Informed consent signed by patient or next of kin

Exclusion Criteria:

Immunosuppressive disorder

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Responsible Party: Globus Medical Inc Identifier: NCT03371316     History of Changes
Other Study ID Numbers: RGC17-001
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No