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Silicone Gel in the Treatment of Cleft Lip Scars

NCT03314090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-10-24

No results posted yet for this study

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.

Conditions

  • Cleft Lip

Interventions

DRUG

Silicone Gels

silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day. The amount used being similar in size to a grain of rice.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-28
Primary Completion
2016-11-29
Completion
2017-10-12

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314090 on ClinicalTrials.gov