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

May 27, 2022 updated by: Wei Jing

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the sideburns mini incision group
Forty patients (the sideburns mini incision group) were treated with sideburns mini incision.
Procedure: sideburns mini incision
The investigators present a new method to calculate the shortest incision for zygomatic fracture, and use this method to calculate the sideburns mini incision for the surgical treatment of zygomatic arch fracture.
Other: the coronal scalp incision group
Forty patients (the coronal scalp incision group) were treated with coronal scalp incision.
Procedure: coronal scalp incision
Coronal scalp incisions were used as control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incision length
Time Frame: during the surgical procedure
Incision length for open reduction and internal fixation of zygomatic arch fractures.
during the surgical procedure
Operative duration
Time Frame: from the beginning to the end of surgery
The length of time spent on operation.
from the beginning to the end of surgery
Postoperative pain
Time Frame: 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.
24 hours after surgery
Postoperative stay
Time Frame: 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.
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.
Postoperative adverse effects
Time Frame: from the end of surgery to 6 months after surgery
Including bleeding, malocclusion, infection, nerve injury, etc.
from the end of surgery to 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Jing

Investigators

  • Study Chair: Wei Jing, Professor, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

May 3, 2022

Study Completion (Actual)

May 3, 2022

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 15, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCHSIRB-D-2021-264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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