Botulinum Toxin for a Better Scar in Cleft Lip Surgery: A Prospective Randomized Control Trial

Abstract

Introduction: An unsightly scar following cleft repair can undo the good work of even an experienced surgeon. A functioning orbicularis oris muscle beneath the lip scar maintains a zone of dynamic tension resulting in a stretched scar. Botulinum toxin type A (BTA) can be used to create a temporary paralysis of the orbicularis muscle during the healing phase. This may lead to better scar formation after a cleft lip repair. Method: The present prospective randomized control trial enrolled 28 infants with unilateral cleft lip undergoing primary lip repair. They were randomized to receive injection of either BTA (botox group) or normal saline (control group) intraoperatively into adjacent orbicularis oris muscle immediately after completion of cleft lip repair. Blinded experts reassessed the scar after 6 months. Objective assessment was undertaken employing Visual Analogue Scale (VAS), Vancouver Scar Scale (VSS), and photographic scar width measurements. Results: Twenty-two subjects were able to complete a follow-up duration of 6 months. Children in the BTA (Botox Group) had a statistically significantly better VAS score and lesser scar width compared to the control group. However, the difference in the VSS score between both groups was not statistically significant. On comparing patients with cleft lip alone with cleft lip and palate, no statistically significant difference was found in VAS, VSS, and scar width. There were no complications associated with the use of botulinum toxin A. Conclusions: Botulinum toxin type A injection is a safe and effective addition to improve scar appearance following cleft lip repair. There was improvement in appearance of the scar in terms of width, but no improvement was seen in the scar pigmentation. The scar outcome is independent of cleft lip classification.

Botulinum toxin type A for preventing and treating cleft lip scarring—A systematic review and meta‐analysis

“…Table 1 summarizes the study characteristics that were included. Four randomized controlled trials (RCTs) were conducted in China, Mexico, and India, with a total of 161 randomized patients 15–18 . The researchers compared 83 scars treated with BTXA to 78 scars treated with a placebo.…”

“…Although BTXA into the underlying dermis could also diffuse into the muscular layer, 4 trials injected BTXA into the subjacent orbicularis oris muscle instead of subcutaneous injection. In addition, Sonane et al 18 showed that there was no statistically significant difference between infants with cleft lip alone or with a cleft of lip and palate on VAS, VSS, and scar width.…”

“…However, the dose for treating infants with CL/P repair scars ranges from 1 to 2 units/kg. This review showed that 4 studies adopted single injection patients in 3 studies who received BTXA injection immediately after CL/P repair 15,16,18 . Navarro's study adopted BTXA injections before primary CL/P repair 17 .…”

“…This review showed that 4 studies adopted single injection patients in 3 studies who received BTXA injection immediately after CL/P repair. 15,16,18 Navarro's study adopted BTXA injections before primary CL/P repair. 17 Tollefson et al 28 also reported the use of preoperative injection of BTXA in infants with cleft lip deformity, and satisfactory aesthetic results were obtained.…”

“…Four randomized controlled trials (RCTs) were conducted in China, Mexico, and India, with a total of 161 randomized patients. [15][16][17][18] The researchers compared 83 scars treated with BTXA to 78 scars treated with a placebo. In this meta-analysis, VSS scores were used in four studies, three of which involved children's CL/P repair and one involving adults' CL/P repair.…”