Temporalis Myofascial Flap Effectiveness

March 25, 2022 updated by: Mina Youssef Asham Gendy, Assiut University

The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects

This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • AssiutU7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with:

    • TMJ ankylosis

      • Osteomyelitis following mucormycosis
      • Following tumor resection like maxillectomy or temporal bone resection
      • Following orbital exentration due to tumors or infections
      • Following massive trauma
      • Facial reanimation

Exclusion Criteria:

  • • History of head & neck embolization as it may compromise blood supply of the flap

    • Extensive tumors involving maxillary artery
    • History of head & neck radiation or chemotherapy
    • Temporalis muscle wasting due to any reason
    • Bad general condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flap survival
Harvesting temporalis myofascial flap for cranio-maxillofacial defects
Procedure: Temporalis Myofascial flap
Improvement of speech and feeding quality in patients with palatal defects by temporalis myofascial flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization
Time Frame: 6 months postoperatively
Assessment by regular follow up by pin bricks
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of phonation and swallowing efficacy postoperatively
Time Frame: 6 months postoperatively
Assessment will be done in regular follow up visits by video fluoroscopy , trials of swallowing and phonation will be assessed by phoniatricians
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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