Back to resultsFree Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients
Primary Purpose
Facial Paralysis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Facial reanimation surgery by free muscle trasfer.
Sponsored by
About this trial
This is an interventional treatment trial for Facial Paralysis
Eligibility Criteria
Inclusion Criteria:
- All patients with facial paralysis more than one year what ever the cause.
Exclusion Criteria:
- patients with uncontrolled diabetes.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Segmental free latissimus muscle trasfer to the face.
Free gracillis muscle trasfer to the face.
Outcomes
Primary Outcome Measures
Change in smile excursion with the two muscles in the paralyzed side from the pre operative state.
We will use SMILE system of Bray et al for assessment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05222698
Brief Title
Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients
Official Title
Segmental Free Latissimus Versus Free Gracillis Muscles Powered by Hypoglossal Nerve in Facial Reanimation of Long-standing Facial Palsy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Segmental free latissimus muscle trasfer to the face.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Free gracillis muscle trasfer to the face.
Intervention Type
Procedure
Intervention Name(s)
Facial reanimation surgery by free muscle trasfer.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in smile excursion with the two muscles in the paralyzed side from the pre operative state.
Description
We will use SMILE system of Bray et al for assessment.
Time Frame
One year post operatively.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients with facial paralysis more than one year what ever the cause.
Exclusion Criteria:
patients with uncontrolled diabetes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Saber, Master
Phone
01005795166
Email
ahmed.osman@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Saber, Master
Organizational Affiliation
Sohag faculty of medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients
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