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临床试验/NCT05568108
NCT05568108招募中不适用

Using the Masseteric Nerve for Facial Nerve Reanimation: A Clinical Study.

Assiut University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Comparing the outcomes on EFACE score

研究概览

简要总结

The return of eyelid function and facial expression in Patients with facial nerve affection is very important for quality of life. Eyelid dysfunction leads to drying and ulceration of cornea which may lead to permanent vision loss.

Facial paralysis is distinguished into two main groups according to the presence or absence of facial fibrillations at needle Electromyography. Recent paralysis, mainly lasting less than two years generally show these signs and are eligible for reactivation of facial nerve by anastomosing it to a donor one (early facial reanimation).

The masseteric nerve (motor branch of trigeminal nerve ) is a reliable donor nerve on early facial reanimation So on this study we examine the advantages and disadvantages of using masseteric nerve to develop a protocol for use of facial reanimation and restoration of function on facial paresis.

详细描述

Type of the study: observtional Study (clinical trial)

Intervention Model Description:

Patients will be two groups according to the surgical procedure performed as follows:

  • Group A: masseteric nerve to central branch facial nerve. (Early fibrillation on EMG)
  • Group B: Masseteric nerve to free functioning muscle transfer. (Late no fibrillation on EMG)

Allocation and Randomization:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Facial nerve affection
  • Patients are generally fit with no other disease interfere with microsurgery.
  • Electromyography showing fibrillations for group A and no fibrillation for group B.

排除标准

  • Patient with other medical or mental disease-causing generalized paralysis.
  • Syndromic cases.
  • Patients are generally unfit or with any disease interfere with microsurgery.

结局指标

主要结局

Comparing the outcomes on EFACE score

时间窗: up to one year

difference on the score

次要结局

  • Effect of addition of contracted growth factor around the anastomosis(up to one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Refaat Ahmed Abdelkarim

assitant lecturer of plastic and reconstructive surgery

Assiut University

研究点 (1)

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