Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.
ConditionUnilateral Cleft Lip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorMansoura University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with mild to severe unilateral cleft lip requiring repair
free from any systemic disease
with or without cleft palate
fit for general anesthesia
Disqualifiers
patients with syndromic type of cleft lip
patients with systemic disease
Trial design
Design model
Parallel
Treatments tested in this trial
Modified Millard rotation advancement flap technique
Procedure/Surgerythe cleft is repaired by surgical intervention
botulinum toxin injection (BTX A) before surgical intervention
Drugthe patient will receive Botulinum toxin type A followed by surgical closure of cleft lip
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Group I : 16 patient with unilateral cleft lip treated with surgical procedure aloneExperimental treatment 1 intervention
Group B: Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgeryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Scar width
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.
Time frame
3 and 6 months follow upSecondary outcomes
1
Vancouver scar scale
it evaluates four factors: pigmentation, pliability, height, and vascularity. it is used to asses treatment.
Time frame
3 and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov