Unilateral Cleft Lip
Conditions
Keywords
botulinum toxin, cleft lip, scar
Brief summary
the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.
Interventions
PROCEDUREModified Millard rotation advancement flap technique
the cleft is repaired by surgical intervention
DRUGbotulinum toxin injection (BTX A) before surgical intervention
the patient will receive Botulinum toxin type A followed by surgical closure of cleft lip
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
: * patients with mild to severe unilateral cleft lip requiring repair * free from any systemic disease * with or without cleft palate * fit for general anesthesia
Exclusion criteria
: * patients with syndromic type of cleft lip * patients with systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar width | 3 and 6 months follow up | Scar width will be measured by independent examiners at two at two certain points using caliper: point 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver scar scale | 3 and 6 months | it evaluates four factors: pigmentation, pliability, height, and vascularity. it is used to asses treatment. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORBasel Saeed Shamaa, Master's
Mansoura University
Outcome results
None listed