Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients

February 1, 2022 updated by: Ahmed Saber Mahmoud, Sohag University

Segmental Free Latissimus Versus Free Gracillis Muscles Powered by Hypoglossal Nerve in Facial Reanimation of Long-standing Facial Palsy Patients

The use of free Neurovascularized muscles like free latissimus and gracillis muscles for reanimation of long-standing facial palsy patients using the hypoglossal nerve for innervating these muscles

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators need to know which of the two muscles is better functionally and aesthetically in facial reanimation of patients with facial paralysis of more than one year duration.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with facial paralysis more than one year what ever the cause.

Exclusion Criteria:

  • patients with uncontrolled diabetes.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Segmental free latissimus muscle trasfer to the face.
Procedure: Facial reanimation surgery by free muscle trasfer.
Muscle flap harvesting from the back or from the thigh to be insetted to the paralyzed side of the face with microvascular anastomosis of the muscle pedicle to facial artery and vein.
ACTIVE_COMPARATOR: Group B
Free gracillis muscle trasfer to the face.
Procedure: Facial reanimation surgery by free muscle trasfer.
Muscle flap harvesting from the back or from the thigh to be insetted to the paralyzed side of the face with microvascular anastomosis of the muscle pedicle to facial artery and vein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in smile excursion with the two muscles in the paralyzed side from the pre operative state.
Time Frame: One year post operatively.
We will use SMILE system of Bray et al for assessment.
One year post operatively.

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Principal Investigator: Ahmed Saber, Master, Sohag faculty of medicine

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 (ANTICIPATED)

April 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

January 15, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (ACTUAL)

February 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-01-11

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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