Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes

NCT04237961 | Unknown

• 1 other identifier: Assiutu123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: There are numerous causes of facial palsy (FP), though hemifacial weakness is often generally termed Bell's palsy, named after the Scottish neurologist Charles Bell, who described sudden onset unilateral facial paralysis in 1821. Virally triggered, acute FP, to which the term Bell's palsy (BP) refers, is one of the most common, and fortunately the most likely condition to result in eventual return to premorbid status; 70% to 90% of patients recover spontaneously. Other causes of FP routinely result in poorer recovery, and the clinician must discern among these to formulate a treatment plan. In facial palsy, paralysis of muscles on the affected side of the face results in loss of forehead creases, loss of the nasolabial fold, lagophthalmos, brow droop, and drooping of the corner of the mouth. In contrast, muscles on the unaffected side of the face no longer have opposing forces. This may cause difficulty in articulation, eating, drinking, and is often cosmetically unacceptable to patients because of asymmetry, especially when speaking, smiling, and laughing. There are significant psychological effects as patients lack the confidence to carry out many daily activities in public, such as appearing in photographs. Although management is difficult, there are a range of reanimation options available. These include nerve grafts, muscle transfers, myofunctional approaches, and microsurgical patches usually for the more severe facial palsies (House-Brackmann grades 4 to 6). However, despite these procedures, facial symmetry may not improve.

Conditions

Facial Palsy

Outcome Measures

Primary Outcomes (1)

• Ancillary Procedures in Patients of Refractory Facial Palsy Patients Selection and Evaluation of the Outcomes

  measurement the change in vertical length of the palpebral fissure of the affected eye before and after the operation

  2 years

Study Arms (3)

Upper third interference

EXPERIMENTAL

Botox \& brow lift

Procedure: Botox and brow lift

Middle third

EXPERIMENTAL

Botox and fat injection

Procedure: Injection

Lower third

EXPERIMENTAL

Suspension suture

Procedure: Suture

Interventions

Botox and brow lift PROCEDURE

Botox injection

Upper third interference

Injection PROCEDURE

Fat injection and botox

Middle third

Suture PROCEDURE

Suspension suture

Lower third

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with refractory Facial Palsy who did not respond well to other concerned interferences and those who presented the maximum benefit possible of a performed procedure.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Interventions

Botulinum Toxins, Type A; Injections; Sutures

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Saleh Ali ElAzoumi, master

CONTACT

00201030842527; salehaljafari89@gmail.com

Ahmed Mohammed Tohamy, master

CONTACT

+201221783834; ahmedtohamy92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients could be divided into three groups according to the anatomical site of interferences: * Group 1: Upper third interferences * Group 2: Mid third interferences * Group 3: Lower third interferences
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients could be divided into three groups according to the anatomical site of interferences: * Group 1: Upper third interferences * Group 2: Mid third interferences * Group 3: Lower third interferences

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: January 23, 2020
• Study Start: January 1, 2019
• Primary Completion: January 28, 2020
• Study Completion: March 28, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)