Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

Study Overview
=================
Brief Summary
-----------------
A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method

Official Title
-----------------
Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)

Conditions
-----------------
Cleft Lip

Intervention / Treatment
-----------------
* Other: Botulinum
* Procedure: Fisher technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With mild to severe cleft lip deformity requiring repair. Neonates up to 1 year of age. Patients with or without cleft palate. Systemically healthy patients. Patients follow postoperative instructions provided by their legal guardians. Exclusion Criteria: Patients with a syndromic type of cleft lip. Patients suffering from relevant systemic and metabolic diseases. Patients suffering from immunosuppressive diseases. Patients suffering from neuromuscular disorders like Myasthenia Gravis. Patients with special needs.

Ages Eligible for Study
-----------------
Minimum Age: 0 Minutes
Maximum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Other: Botulinum<br>* injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.<br>|
| Active Comparator: Group B<br> | Procedure: Fisher technique<br>* The cleft lip will be treated surgically using the Fisher technique only.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cleft scar | Vancouver Scar Scale: This scale focuses on four parameters: scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point | 2 weeks, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scar width | The scar width is to be measured at two certain points using digital caliper, one point is 1 mm above white line and the second point is 1 mm below nasal | 2 weeks, 3 months, 6 months | 
| Change in lip height | The lip height measurement will be done using digital caliper at cleft and non-cleft side. | 2 weeks, 3 months, 6 months |