Silicone Gel in the Treatment of Cleft Lip Scars
Condition: Cleft Lip
MeSH terms: Cleft Lip
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Silicone Gels
Intervention type(s): Drug
Intervention description(s): silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day. The amount used being similar in size to a grain of rice.
Other intervention name(s): Dermatix Ultra
Intervention model: Single Group Assignment
Intervention model description: Testing silicone gel in the treatment of upper lip scar
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cleft lip; Scar; Silicone sheet; Silicone gel