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临床试验/NCT03371316
NCT03371316撤回不适用

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

Globus Medical Inc0 个研究点开始时间: 2018年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Adhesion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Immunosuppressive disorder

研究组 & 干预措施

Hemicraniectomy Surgery with Viashield

Experimental

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

干预措施: ViaShield (Biological)

结局指标

主要结局

Adhesion

时间窗: 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

次要结局

  • Infections(From time of surgery to 8 months post-operative)
  • hydrocephalus(From time of surgery to 8 months post-operative)

研究者

申办方类型
Industry
责任方
Sponsor

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