Comparative Study Between Platelet- Rich Fibrin Versus Nano-Fat in Improving Facial Nerve Regeneration After Traumatic Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Physical examination of the affected facial muscles after injury and Record the time taken for the first muscle excursion to occur following each facial nerve repair modality
研究概览
简要总结
The current clinical trial aims to identify the most significant intervention that improves the outcome of post-traumatic facial nerve injury by comparing the following different modalities: neurorrhaphy alone, neurorrhaphy with PRF injection, and neurorrhaphy with Nanofat stem cells graft injection for significantly better Facial nerve regeneration.
详细描述
Despite advances in microsurgical technology and an improved understanding of nerve regeneration, obtaining satisfactory results after facial nerve injury remains a challenging clinical problem.
Traumatic facial nerve injury may account for up to 10% of the causes of facial nerve palsy and has devastating effects on patients both functionally, emotionally, and aesthetically.
The most common traumatic causes of facial paralysis are resection of tumors, temporal bone fractures, and penetrating trauma to the facial nerve, including iatrogenic injury.
Patients with Facial paralysis are at a higher risk of developing adverse psychological outcomes such as depression, anxiety, and disrupted social interaction.
Facial paralysis has implications for patients' quality of life due to the facial nerve's role in myriad activities of daily living.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Sample Size and Group Allocation: A total of 21 patients will be randomly assigned to one of three groups: A, B, or C, with 7 patients in each group.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent Facial nerve injury within the first 24 hours of trauma.
- •Grade V according to Sunderland classification.
排除标准
- •Diabetes Mellitus.
- •Steroid Dependent.
结局指标
主要结局
Physical examination of the affected facial muscles after injury and Record the time taken for the first muscle excursion to occur following each facial nerve repair modality
时间窗: 12 months
\*\*Record the First Occurrence of Muscle Excursion and Movement by facial nerve Physical examination\*\* Based on monthly follow-up records Physical examination of the facial muscles affected after the nerve repair is done. Record the time taken for the first muscle excursion ( movement) to occur following each facial nerve repair modality. Comparing the time interval for each modality - the earlier the occurrence, the better the outcome.
次要结局
未报告次要终点
研究者
Doaa Mohie Selim
Specialist
Assiut University