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

Zygomatic Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381337
• Other study ID #: WCHSIRB-D-2021-264
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 3, 2022

Study information

• Verified date: May 2022
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 mini incision calculated by this method.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 3, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Zygomatic Fractures

Intervention

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.
• coronal scalp incision
Coronal scalp incisions were used as control group.

Locations

Country	Name	City	State
China	Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Wei Jing

Country where clinical trial is conducted

China, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.1177/194338 — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Jun 29. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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