NCT05222698

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

January 15, 2022

Last Update Submit

February 1, 2022

Conditions

Facial Paralysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year post operatively.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Segmental free latissimus muscle trasfer to the face.

Procedure: Facial reanimation surgery by free muscle trasfer.

Group B

ACTIVE COMPARATOR

Free gracillis muscle trasfer to the face.

Procedure: Facial reanimation surgery by free muscle trasfer.

Interventions

Facial reanimation surgery by free muscle trasfer.PROCEDURE

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.

Group AGroup B

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with uncontrolled diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Saber, Master

    Sohag faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Saber, Master

CONTACT

01005795166ahmed.osman@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of plastic surgery

Study Record Dates

First Submitted

January 15, 2022

First Posted

February 3, 2022

Study Start

April 1, 2022

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share