Facial ParalysisNCT05222698
Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients
A study testing Facial reanimation surgery by free muscle trasfer. in people with Facial Paralysis, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- Facial reanimation surgery by free muscle trasfer.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with facial paralysis more than one year what ever the cause.
Who cannot join
- patients with uncontrolled diabetes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Facial Paralysis
- Being tested
- Facial reanimation surgery by free muscle trasfer.
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial reanimation surgery by free muscle trasfer.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Segmental free latissimus muscle trasfer to the face. Receives: Procedure: Facial reanimation surgery by free muscle trasfer. |
| Group B | Active comparator | Free gracillis muscle trasfer to the face. Receives: Procedure: Facial reanimation surgery by free muscle trasfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study startApr 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saber Mahmoud, Sohag University
- Investigators
- Ahmed Saber, Master, Principal investigator, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222698
- Sponsor's protocol ID
- Soh-Med-22-01-11
- Status last verified
- Feb 2022
- First submitted
- 15 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Free Latissimus Versus Free Gracillis Muscles Powered by Hypoglossal Nerve in Facial Reanimation of Long-standing Facial Palsy Patients
- ClinicalTrials.gov ID
- NCT05222698
- Acronym / sponsor ID
- Soh-Med-22-01-11
- Conditions
- Facial Paralysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Facial reanimation surgery by free muscle trasfer.Segmental free latissimus muscle trasfer to the face. |
| Group B | Active comparator | Procedure: Facial reanimation surgery by free muscle trasfer.Free gracillis muscle trasfer to the face. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with facial paralysis more than one year what ever the cause.
Key exclusion criteria (1 listed)
- patients with uncontrolled diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group A, Group B |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Saber, Master principal investigator
Sohag faculty of medicine
Questions about this trial
What is this clinical trial studying?
A study testing Facial reanimation surgery by free muscle trasfer. in people with Facial Paralysis, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Saber, Master (01005795166, ahmed.osman@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smile excursion with the two muscles in the paralyzed side from the pre operative state. (time frame: One year post operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.