Actively Recruiting
Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial
Led by Mansoura University · Updated on 2026-02-10
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies patients with unilateral cleft lip to evaluate the effect of botulinum toxin type A injection on reducing scarring after cleft lip surgery. The goal is to see if adding this injection before surgical repair can improve scar appearance. The trial is randomized and controlled to compare outcomes in two groups. Participants are divided into two groups: one receiving only the surgical repair using the Modified Millard rotation advancement flap technique, and the other receiving botulinum toxin type A injection before surgery. The study measures scar width and appearance at 3 and 6 months after treatment. Participants will be followed up at 3 and 6 months to assess scar width and use the Vancouver scar scale for scar evaluation. The research team will monitor healing and outcomes after surgery and injection. This follow-up helps determine the intervention's impact on scar reduction over several months.
CONDITIONS
Brief Title
Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with mild to severe unilateral cleft lip requiring repair
- Free from any systemic disease
- With or without cleft palate
- Fit for general anesthesia
You will not qualify if you...
- Patients with syndromic type of cleft lip
- Patients with systemic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo cleft lip repair using the Modified Millard rotation advancement flap technique with or without botulinum toxin injection before surgery.
1 visit (in-person)
Duration - 6 months
Participants are monitored for scar development and healing after surgery.
2 visits at 3 and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Mansoura University
Al Mansurah, Egypt
Actively Recruiting
Research Team
B
Basel Saeed Shamaa, Master's
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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