Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.

Mansoura University

Status: Active, not recruiting

Conditions: Unilateral Cleft Lip

Treatments: Procedure: Modified Millard rotation advancement flap technique; Drug: botulinum toxin injection (BTX A) before surgical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07137234

M0101025OS

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 10+ weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

inclusion criteria :

1. patients with mild to severe unilateral cleft lip requiring repair
2. free from any systemic disease
3. with or without cleft palate exclusion criteria :

1- patients with syndromic type of cleft lip 2- patients with systemic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 2 patient groups

Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone

Experimental group

Treatment:

Procedure: Modified Millard rotation advancement flap technique

Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery

Experimental group

Treatment:

Drug: botulinum toxin injection (BTX A) before surgical intervention

Procedure: Modified Millard rotation advancement flap technique