Does the Deep Layer of the Deep Temporalis Fascia Really Exist?

Sponsor

West China College of Stomatology (Other)

Overall Status

Completed

CT.gov ID

NCT03308318

Collaborator

(none)

167

Enrollment

47.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anatomy Temporal Region Trauma	Procedure: The supratemporalis approach

Detailed Description

The anatomic layers of soft tissues of the temporal region, with regard to the deep temporalis fascia, was investigated in 169 cases operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach from June 2013 to June 2017. Among 167 surgeries, this so-called "deep layer of the deep temporalis fascia" was not observed. In fact, the superficial temporal fat pad is closely attached to temporal muscle above the zygomatic arch.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

167 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

A New Discovery on the Temporal Fascial Layers: Does the Deep Layer of the Deep Temporalis Fascia Really Exist?

Actual Study Start Date :

Jun 17, 2013

Actual Primary Completion Date :

Jun 13, 2017

Actual Study Completion Date :

Jun 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
the supratemporalis approach patients operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach	Procedure: The supratemporalis approach 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.

Arm

Intervention/Treatment

the supratemporalis approach

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

Procedure: The supratemporalis approach

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

West China College of Stomatology

Investigators

Study Director: Lei Liu, DMD, Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hui Li, Principal Investigator, West China College of Stomatology

ClinicalTrials.gov Identifier:

NCT03308318

Other Study ID Numbers:

hui_owe

First Posted:

Oct 12, 2017

Last Update Posted:

Oct 13, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hui Li, Principal Investigator, West China College of Stomatology

Deep temporal fascia

Deep layer of the deep temporal fascia

Superficial layer of the deep temporal fascia

Temporal fascial layers

Temporal anatomy

Additional relevant MeSH terms:

Craniocerebral Trauma

Study Results

No Results Posted as of Oct 13, 2017