Silicone Gel in the Treatment of Cleft Lip Scars
Silicone Gel in the Treatment of Cleft Lip Scars
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.
The control group consisted of 29 patients who were recruited and became controls for a
 previous study (Botulinum Toxin to Improve Results in Cleft Lip Repair; IRB No 101-3009C) who
 were treated using the current established protocol for scar care following cheiloplasty 2.
 This involved microporous tape placed across both cheeks and spanning the upper lip during
 daytime, and silicone sheets fixed with a shorter length of microporous tape (that did not
 span the cheeks) at night. This continued strictly for 6 months.

 The Study group consisted of another 33 consecutive age-matched patients with unilateral
 cleft lip, whose postoperative scar care was exactly the same except the silicone sheet was
 replaced with silicone gel (Dermatix Ultra, Menarini, Singapore), which was applied twice per
 day. The parents (or caregivers) were instructed to apply silicone gel (the amount being
 similar in size to a grain of rice) along the upper lip scar from the nostril base to the
 vermillion, avoiding the wet mucosa.

 Inclusion criteria were: 1. Baby born with cleft lip planned for primary lip repair around 3
 months of age, . Written informed consent for the study provided by the parent/guardian.
 Exclusion criteria were: 1. presence of other craniofacial anomalies; 2. lack of signed
 informed consent from the parent/guardian.
Inclusion Criteria:

 -  Baby born with cleft lip planned for primary lip repair around 3 months of age,

 -  Written informed consent for the study provided by the parent/guardian

 Exclusion Criteria:

 -  presence of other craniofacial anomalies;

 -  lack of signed informed consent from the parent/guardian.