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

NCT ID: NCT03371316

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-20
• Study Completion Date: 2018-01-30

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.

Conditions

Hemicraniectomies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemicraniectomy Surgery with Viashield

All patients requiring a hemicraniectomy surgery will receive the anti-adhesion barrier of amnion patch.

Group Type: EXPERIMENTAL

ViaShield

Intervention Type: BIOLOGICAL

Anti-adhesion scores using amnion patch

Interventions

ViaShield

Anti-adhesion scores using amnion patch

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Immunosuppressive disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Globus Medical Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RGC17-001

Identifier Type: -

Identifier Source: org_study_id