NCT03308318

Brief Summary

It has been widely accepted that a split of the deep temporal fascia occurs approximately 2 to 3 cm above the zygomatic arch, named the superficial and deep layers. The deep layer of the deep temporal fascia lies between superficial temporal fat pad and the temporal muscle. However, during the investigators' previous surgeries, the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle. This study was conducted to clarify the presence or absence of the deep layer of the deep temporal fascia. And the investigators' clinical study has confirmed the absence of the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

October 5, 2017

Last Update Submit

October 11, 2017

Conditions

Keywords

Deep temporal fasciaDeep layer of the deep temporal fasciaSuperficial layer of the deep temporal fasciaTemporal fascial layersTemporal anatomy

Outcome Measures

Primary Outcomes (1)

  • deep layer of the deep temporal fascia

    the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle

    during surgery

Study Arms (1)

the supratemporalis approach

patients operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach

Procedure: The supratemporalis approach

Interventions

The incision differs according to specific fracture sites. It can be a hockey stick-shaped incision, hemicoronal incision, and full coronal incision. The first layer of dissection was just under the superficial temporalis fascia.Then, approximately at the level of 3-5cm above the zygomatic arch, our modified incision was carried through the deep temporalis fascia.Next, the superficial fat pad was encountered and retracted anteriorly, which was in close contact of the temporal muscle. Finally, a flap that included skin, subcutaneous tissue, the superficial temporal fascia, the areolar fat tissue, the deep temporalis fascia and the superficial temporal fat was reflected as a whole anteriorly, fully exposing the temporal muscle and zygomatic arch.

the supratemporalis approach

Eligibility Criteria

Age10 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and received surgical treatment from the Dr. Lei Liu

You may qualify if:

  • Clinical and imaging diagnosis of zygomaticofacial or craniofacial fractures A need to operate using the supratemporalis approach No previously surgical treatment

You may not qualify if:

  • unobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (29)

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    PMID: 2911626BACKGROUND
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    PMID: 3941846BACKGROUND
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    PMID: 1741467BACKGROUND
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    PMID: 298842BACKGROUND
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    PMID: 22705217BACKGROUND
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    PMID: 26844401BACKGROUND
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    PMID: 20083736BACKGROUND
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    PMID: 16192853BACKGROUND
  • Tremolada C, Candiani P, Signorini M, Vigano M, Donati L. The surgical anatomy of the subcutaneous fascial system of the scalp. Ann Plast Surg. 1994 Jan;32(1):8-14. doi: 10.1097/00000637-199401000-00002.

    PMID: 8141539BACKGROUND
  • Ramirez OM, Maillard GF, Musolas A. The extended subperiosteal face lift: a definitive soft-tissue remodeling for facial rejuvenation. Plast Reconstr Surg. 1991 Aug;88(2):227-36; discussion 237-8.

    PMID: 1852815BACKGROUND
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    PMID: 20679939BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Lei Liu, DMD

    Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 12, 2017

Study Start

June 17, 2013

Primary Completion

June 13, 2017

Study Completion

June 13, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share