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

Not Applicable

Completed

• Conditions: Zygomatic Fractures
• Interventions: Procedure: sideburns mini incision; Procedure: coronal scalp incision

• Registration Number: NCT05381337
• Lead Sponsor: Wei Jing

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-05
• Primary Completion: 2022-05-03
• Study Completion: 2022-05-03
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-15
• Study First Posted: 2022-05-19
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Clinical and imaging diagnosis of zygomatic arch fracture or zygomatic maxillary complex fracture.
2. 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.
3. No previous surgical treatment.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the sideburns mini incision group	sideburns mini incision	Forty patients (the sideburns mini incision group) were treated with sideburns mini incision.
the coronal scalp incision group	coronal scalp incision	Forty patients (the coronal scalp incision group) were treated with coronal scalp incision.

Primary Outcome Measures

Name	Time	Method
Postoperative adverse effects	from the end of surgery to 6 months after surgery	Including bleeding, malocclusion, infection, nerve injury, etc.
Incision length	during the surgical procedure	Incision length for open reduction and internal fixation of zygomatic arch fractures.
Postoperative stay	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	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	from the beginning to the end of surgery	The length of time spent on operation.

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University; 🇨🇳 Chengdu, Sichuan, China