跳至主要内容
临床试验/NCT05381337
NCT05381337已完成不适用

A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture: Sideburns Mini Incision

Wei Jing1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Postoperative adverse effects

研究概览

简要总结

In this study, a new method was proposed to calculate the length of sideburns mini incision for zygomatic arch fracture. The purpose of this study was to compare the sideburns mini incision calculated by this method with the coronal scalp incision, so as to determine the therapeutic effect and advantages of sideburns mini incision calculated by this method.

详细描述

Eighty patients with zygomatic arch fracture were treated with surgical intervention. Forty patients were treated with sideburns mini incision, and the other forty patients were treated with coronal scalp incision. Data such as incision length, operation time and postoperative complications were recorded. The follow-up periods were 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical and imaging diagnosis of zygomatic arch fracture or zygomatic maxillary complex fracture.
  • •Fracture fragments are obviously displaced, which affects the appearance and function of the patient. Simple prying is instable and requires open reduction and internal fixation.
  • •No previous surgical treatment.

排除标准

  • •Accompanied by multiple fractures of mandible, nasal bone and so on.
  • •There are traumatic scars in the operation area, which can be accessed through the original wound.
  • •History of bone disease and / or wound healing disorders.
  • •Mental and intellectual disorders.

研究组 & 干预措施

the coronal scalp incision group

Other

Forty patients (the coronal scalp incision group) were treated with coronal scalp incision.

干预措施: coronal scalp incision (Procedure)

the sideburns mini incision group

Experimental

Forty patients (the sideburns mini incision group) were treated with sideburns mini incision.

干预措施: sideburns mini incision (Procedure)

结局指标

主要结局

Postoperative adverse effects

时间窗: from the end of surgery to 6 months after surgery

Including bleeding, malocclusion, infection, nerve injury, etc.

Incision length

时间窗: during the surgical procedure

Incision length for open reduction and internal fixation of zygomatic arch fractures.

Postoperative stay

时间窗: From the end of surgery until discharge, up to 15 days. After evaluation by the same chief knife physician, the patient recovered well postoperatively and could be discharged.

Days of postoperative hospital stay was calculated to evaluate patient recovery.

Postoperative pain

时间窗: 24 hours after surgery

Visual Analogue Scale was used to evaluate the burden of postoperative pain. The maximum score is 10, and the minimum score is 0. Higher scores represent more intense pain.

Operative duration

时间窗: from the beginning to the end of surgery

The length of time spent on operation.

次要结局

未报告次要终点

研究者

发起方
Wei Jing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wei Jing

Professor

Sichuan University

研究点 (1)

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