Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

Hams Hamed Abdelrahman

Status: Completed

Conditions: Cleft Lip

Treatments: Procedure: Fisher technique; Other: Botulinum

Study type: Interventional

Funder types: Other

Identifiers

NCT05559281

Botulinum_2020

Details and patient eligibility

About

A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method

Enrollment: 22 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With mild to severe cleft lip deformity requiring repair.
• Neonates up to 1 year of age.
• Patients with or without cleft palate.
• Systemically healthy patients.
• Patients follow postoperative instructions provided by their legal guardians.

Exclusion criteria

• Patients with a syndromic type of cleft lip.
• Patients suffering from relevant systemic and metabolic diseases.
• Patients suffering from immunosuppressive diseases.
• Patients suffering from neuromuscular disorders like Myasthenia Gravis.
• Patients with special needs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Group A

Experimental group

Treatment:

Other: Botulinum

Group B

Active Comparator group

Treatment:

Procedure: Fisher technique