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Zygomatic FracturesNCT05381337

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

A study testing sideburns mini incision and coronal scalp incision in people with Zygomatic Fractures, run by Wei Jing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 65 years
Conditions the study is for
Zygomatic Fractures
What is being tested?
sideburns mini incision and coronal scalp incision
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Jan 2021to 3 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
sideburns mini incision, coronal scalp incision
Keywords
Zygomatic Arch, Fracture Fixation
Medical subject headings
Zygomatic Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sideburns mini incisionProcedure or surgery

    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 incisionProcedure or surgery

    Coronal scalp incisions were used as control group.

Study groups in NCT05381337
Study groupRoleWhat they receive
the sideburns mini incision groupExperimentalForty patients (the sideburns mini incision group) were treated with sideburns mini incision.
Receives: Procedure: sideburns mini incision
the coronal scalp incision groupOtherForty patients (the coronal scalp incision group) were treated with coronal scalp incision.
Receives: Procedure: coronal scalp incision

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incision length

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

    Measured: during the surgical procedure

  2. Operative duration

    The length of time spent on operation.

    Measured: from the beginning to the end of surgery

  3. Postoperative pain

    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.

    Measured: 24 hours after surgery

  4. Postoperative stay

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

    Measured: 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.

  5. Postoperative adverse effects

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

    Measured: from the end of surgery to 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start1 Jan 2021
  3. Primary completion3 May 2022
  4. Study completion3 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381337
Sponsor's protocol ID
WCHSIRB-D-2021-264
Status last verified
May 2022
First submitted
6 May 2022
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang L, Jiang C, Lin Y, Wen Y, Huang X, Huang J, Lin L. Analysis of Maxillofacial Fractures Based on the Etiology in Southeast China: A 10-Year, Multi-Center Study. J Craniofac Surg. 2021 Jun 1;32(4):1432-1435. doi: 10.1097/SCS.0000000000007183.

    PubMed 33038178

  • Tent PA, Juncar RI, Juncar M. Epidemiological Analysis of Zygomatic Bone Fractures in North-Western Romanian Population: A 10-Year Retrospective Study. In Vivo. 2020 Jul-Aug;34(4):2049-2055. doi: 10.21873/invivo.12006.

    PubMed 32606181

  • Kim JH, Kim YS, Oh DY, Jun YJ, Rhie JW, Moon SH. Efficacy of Altered Two-Point Fixation in Zygomaticomaxillary Complex Fracture. Biomed Res Int. 2020 Mar 18;2020:8537345. doi: 10.1155/2020/8537345. eCollection 2020.

    PubMed 32258152

  • Panneerselvam E, Balasubramanian S, Kempraj J, Babu VR, Raja VBKK. Management of Zygomatic Arch Fractures by Intraoral Open Reduction and Transbuccal Fixation: A Technical Note. Craniomaxillofac Trauma Reconstr. 2020 Jun;13(2):130-132. doi: 10.1177/1943387520911866. Epub 2020 Mar 17.

    PubMed 32642044

  • Cheon JS, Seo BN, Yang JY, Son KM. Clinical Follow-up on Sagittal Fracture at the Temporal Root of the Zygomatic Arch: Does It Need Open Reduction? Arch Plast Surg. 2013 Sep;40(5):546-52. doi: 10.5999/aps.2013.40.5.546. Epub 2013 Sep 13.

    PubMed 24086808

  • Birgfeld CB, Mundinger GS, Gruss JS. Evidence-Based Medicine: Evaluation and Treatment of Zygoma Fractures. Plast Reconstr Surg. 2017 Jan;139(1):168e-180e. doi: 10.1097/PRS.0000000000002852.

    PubMed 28027253

  • Strong EB, Gary C. Management of Zygomaticomaxillary Complex Fractures. Facial Plast Surg Clin North Am. 2017 Nov;25(4):547-562. doi: 10.1016/j.fsc.2017.06.006.

    PubMed 28941507

  • Ling XF, Yew CC, Mohd Nazri SB, Tew MM. Unilateral Zygomatic Complex Fracture - A Comparison Between Nonsurgical Treatment and Surgical Treatment. J Craniofac Surg. 2021 Oct 1;32(7):e627-e630. doi: 10.1097/SCS.0000000000007603.

    PubMed 33654041

  • Sanada Y, Yabuuchi T, Yoshioka H, Kubota H, Kato A. Zigzag skin incision effectively camouflages the scar and alopecia for moyamoya disease: technical note. Neurol Med Chir (Tokyo). 2015;55(3):210-3. doi: 10.2176/nmc.tn.2014-0193. Epub 2015 Feb 20.

    PubMed 25739436

  • Ji SY, Kim SS, Kim MH, Yang WS. Surgical Methods of Zygomaticomaxillary Complex Fracture. Arch Craniofac Surg. 2016 Dec;17(4):206-210. doi: 10.7181/acfs.2016.17.4.206. Epub 2016 Dec 23.

    PubMed 28913285

  • Verpaele A, Tonnard P, Gaia S, Guerao FP, Pirayesh A. The third suture in MACS-lifting: making midface-lifting simple and safe. J Plast Reconstr Aesthet Surg. 2007;60(12):1287-95. doi: 10.1016/j.bjps.2006.12.012. Epub 2007 Jun 29.

    PubMed 17604708

  • Chopan M, Buchanan PJ, Mast BA. The Minimal Access Cranial Suspension Lift. Clin Plast Surg. 2019 Oct;46(4):547-557. doi: 10.1016/j.cps.2019.06.005. Epub 2019 Aug 2.

    PubMed 31514807

Questions about this trial

What is this clinical trial studying?

A study testing sideburns mini incision and coronal scalp incision in people with Zygomatic Fractures, run by Wei Jing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incision length (time frame: during the surgical procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05381337, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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