Silicone Gel in the Treatment of Cleft Lip Scars

October 22, 2017 updated by: Chang Gung Memorial Hospital

Clinical Evaluation of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Chun Shin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silicone Gel Group
Intervention: Silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day (BID). The amount being similar in size to a grain of rice.
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.
Other Names:
  • Dermatix Ultra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vacouver scar scale
Time Frame: Six months after surgery

Pigmentation: 0 normal; 1 hypopigmentation; 2 Hyperpigmentation Vascularity: 0 normal; 1. pink; 2. red; 3. purple Pliability: 0 normal; 1. supple, flexible with minimal resistance; 2. Yielding, giving way to pressure; 3. firm, inflexible, not easily moved, resistant to manual pressure; 4. banding, rope-like tissue that blanches with extension of the scar; 5. contracture, permanent shortening of the scar producing deformity or distortion.

Height: 0. normal; 1. less than 2 mm; 2. less than 5 mm; 3. more than 5 mm The sum of each item give the total scores. The score range from 0-13; with minimum of 0 being the best scar and maximum13 the worst scar
Six months after surgery
Visual Analogue Scale
Time Frame: Six months after surgery
VAS with 10 grades: 0 represented the worst possible scar outcome and 10 the best possible scar outcome.
Six months after surgery
Scar width
Time Frame: Six months after surgery
A standard frontally oriented photograph was taken with a surgical ruler placed on the lower lip at the six-month follow up clinic. The scar width measurements were obtained from the photographs (using the surgical ruler as the reference) by two independent raters and means calculated. A commercial photograph program for scar width measurement was utilized (Photoshop CS5 extended version 12.0; Adobe Systems Inc, San Jose, California). Scars were measured at two points: the First Point was 1 mm above the white roll; the Second Point was 1 mm below the C-flap suture line.
Six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2014

Primary Completion (Actual)

November 29, 2016

Study Completion (Actual)

October 12, 2017

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 22, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102-4719b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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