Cleft lip / palate is the most common craniofacial anomaly in humans. Lip repair is one of
the most important reconstructions for these patients, and is performed at around 3 months of
age. Although the cheiloplasty scar is unavoidable and permanent, every possible measure
should be considered to optimize its functional and aesthetic outcome, since the scar can be
a lifelong social stigma of a cleft lip operation. Hypertrophic scarring can highlight the
scar even further, and is a recognized negative outcome for cheiloplasty. Moreover, with an
incidence as high as 36.3% , hypertrophic scars are more common in Asian-Orientals compared
to Caucasians.
The population treated at investigator's institution is almost entirely Oriental (Taiwanese).
Patients' intrinsic higher risk of hypertrophic scarring has led investigators continuously
to try to improve scar quality for them. In 2011, investigator started a double-blinded,
randomized, vehicle-controlled, prospective clinical trial to evaluate whether the injection
of botulinum toxin A into the orbicularis oris muscle could improve the quality of the cleft
lip scar . The results revealed that botulinum toxin injections into the subjacent
orbicularis oris muscle produced narrower cheiloplasty scars, but provided no additional
benefits in terms of scar pigmentation, vascularity, pliability or height. During that study,
the parents of 14% (4/29) of the babies within the control group reported that participant
baby had tried, albeit unsuccessfully, to ingest the silicone sheet at night. This caused
investigator to question the safety of silicone sheeting on the upper lip in babies.
Silicone is known to be effective for treating and/or preventing hypertrophic scarring .
Silicone gel has been shown to prevent hypertrophic scars in median sternotomy wounds 8.
Investigators therefore conducted this clinical trial to evaluate whether post-operative use
of silicone gel was non-inferior to silicone sheet for preventing hypertrophy of unilateral
cleft lip repair scars.