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Botulinum Toxin to Improve Results in Cleft Lip Repair

Chang, Chun-Shin M.D.; Wallace, Christopher Glenn M.D., M.S.; Hsiao, Yen-Chang M.D.; Chang, Chee-Jen Ph.D.; Chen, Philip Kuo-Ting M.D.

Plastic and Reconstructive Surgery: September 2014 - Volume 134 - Issue 3 - p 511–516
doi: 10.1097/PRS.0000000000000416
Pediatric/Craniofacial: Original Articles
Video Discussion
Best Paper

Background: Upper lip wounds that lie perpendicular to the relaxed skin tension lines are subjected to repetitive dynamic tension caused by the orbicularis oris muscle and are susceptible to unsatisfactory scarring.

Methods: In this double-blind, randomized, vehicle-controlled, prospective trial, 60 consecutive patients with unilateral cleft lip undergoing primary cheiloplasties between August of 2011 and June of 2012 were randomized to receive botulinum toxin type A or vehicle injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were assessed after 6 months using the Vancouver Scar Scale, photographic visual analogue scale, and photographic scar width measurements.

Results: Fifty-nine patients completed the trial. Measurements of scar widths at two defined points revealed significantly better visual analogue scale scores and narrower scars in the experimental group. However, Vancouver Scar Scale assessments were similar between groups.

Conclusions: Botulinum toxin injections into the subjacent orbicularis oris muscle produced better appearing and narrower cheiloplasty scars, but provided no additional benefits in terms of scar pigmentation, vascularity, pliability, or height.


Video Discussion by Michael Bentz, M.D., is available online for this article.

Taoyuan, Taiwan

From the Graduate Institute of Biochemical and Biomedical Engineering, College of Engineering, and the Graduate Institute of Clinical Medical Sciences, School of Medicine, Chang Gung University; and the Craniofacial Research Center, Department of Medical Research, Department of Plastic Surgery, Chang Gung Memorial Hospital.

Received for publication September 14, 2013; accepted January 23, 2014.

This trial is registered under the name “Botulinum Toxin to Improve Results in Cleft Lip Repair,” Clinical identification number NCT01429402 (

Disclosure: None of the authors has a financial interest in any of the products or devices mentioned in this article.

A Video Discussion by Michael Bentz, M.D., accompanies this article. Go to and click on “Video Discussions” in the “Videos” tab to watch.

Philip Kuo-Ting Chen, M.D., Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital, 5, Fu-Hsing Street, Kuei-Shan Hsien, Taoyuan 333, Taiwan,

©2014American Society of Plastic Surgeons