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Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded,Randomized, Vehicle-Controlled Clinical Trial
Authors:Chun-Shin Chang  Christopher Glenn Wallace  Yen-Chang Hsiao  Chee-Jen Chang  Philip Kuo-Ting Chen
Institution:1. Graduate Institute of Chemical and Materials Engineering, College of Engineering, Chang Gung University, Taoyuan, Taiwan.; 2. Graduate Institute of Clinical Medical Sciences, School of Medicine, Chang Gung University, Taoyuan, Taiwan.; 3. Craniofacial Research Center, Department of Medical Research, Department of Plastic Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan.; University of Toronto, Canada,
Abstract:

Background

Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds.

Methods

In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths.

Results

58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group.

Conclusion

Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing.

Trial Registration

ClinicalTrials.gov NCT01429402
Keywords:
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