Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.

Mansoura University32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Unilateral Cleft Lip

Interventions

Modified Millard rotation advancement flap techniquePROCEDURE

the cleft is repaired by surgical intervention

botulinum toxin injection (BTX A) before surgical interventionDRUG

the patient will receive Botulinum toxin type A followed by surgical closure of cleft lip

Eligibility

Sex: ALLMin age: 10 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

Outcomes

Primary Outcomes

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 up

Secondary Outcomes

Vancouver scar scale

it evaluates four factors: pigmentation, pliability, height, and vascularity. it is used to asses treatment.

Time frame: 3 and 6 months

Central Contacts

Basel Saeed Shamaa, Master's

CONTACT

+201067705286 baselshamaa@mans.edu.eg

Data from ClinicalTrials.gov

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