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NCT Number: NCT05381337

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

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.

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Key information

Conditions

Zygomatic Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

sideburns mini incision

Procedure

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.

coronal scalp incision

Procedure

Coronal scalp incisions were used as control group.

Primary outcomes

  1. Incision length

    Time frame: during the surgical procedure

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

  2. Operative duration

    Time frame: from the beginning to the end of surgery

    The length of time spent on operation.

  3. 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.

  4. 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.

  5. Postoperative adverse effects

    Time frame: from the end of surgery to 6 months after surgery

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

Sponsors and collaborators

Lead sponsor

Wei Jing

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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