Use of the type A botulinum toxin in patients submitted to cheiloplasty to improve results in scarring in patients with nonsyndromic cleft lip and palate
Cleft lip, and its association with cleft palate, is the most common craniofacial malformation worldwide, having a high incidence in the Hispanic population, with 9.6 cases being reported per 10,000 newborns. The standard treatment is cheiloplasty with satisfying functional result. However, the presence of the hypertrophic scar constitutes the most frequent sequel, requiring, in some cases, a new surgery. Said scar often becomes a social stigma of this pathology.
Aim: To determine if the application of type A botulinum toxin prior to the surgery, improves the aesthetical results of the surgery evaluated by the Vancouver scale.
A randomized triple-blind clinical trial was performed that included all patients from 4 to 24 months of age, with unilateral or bilateral cleft lip and palate, without any history of prior surgery, at the HRAEB in Mexico. The surgery was performed by the same senior surgeon in both groups. Patients were randomized into two groups: a study group of 11 patients who received a type A Botulinum toxin injection at least 7 days before the surgery and a control group of 11 patients who received placebo. Both groups were evaluated by a different investigator, 3 and 6 months postoperatively using the Vancouver scale.
There was statistical significance in the width of the scar in millimeters, in the study group, of 2 mm (0–3) and in the control group of 4 mm with p value of < 0.001. There was also a difference in Vancouver scale, obtaining in the study group a mean of 2 points (IC 0–3) and in the control group one of 4 points (IC 0–6) with a p value of < 0–001. No side effects of the toxin were documented during the study and there were less surgical complications.
The use of type A botulinum toxin decreases the presence of a hypertrophic scar in patients with a cleft lip who undergo primary cheiloplasty; however, more studies with a larger number of patients are needed.
Level of evidence: level II, therapeutic study.
KeywordsCleft lip Botulinum toxin Cheiloplasty
Compliance with ethical standards
The clinical trial was approved by the hospital committee of ethics and clinical research, with the number CEI 00420170731. Informed consent was explained and provided to patient parent before the intervention and attached to its clinical file.
Conflict of interest
David Felipe Navarro-Barquín, Edgard Efren Lozada-Hernández, Myriam Tejeda-Hernández, Gerardo Adrian DeLeon-Jasso, Freya Estefania Morales-Rescalvo, Eduardo Flores-González, Felipe Piña-Aviles declare that there is no conflict of interest and have no ties with the pharmaceutical industry.
The financial support for this research was offered by Hospital Regional de Alta Especialidad del Bajio that supplied the Botulinum toxin for the administration to the selected patients.
Patients provided written consent for the use of their images.
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