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Silicone Gel in the Treatment of Cleft Lip Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03314090
Recruitment Status : Completed
First Posted : October 19, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cleft Lip Drug: Silicone Gels Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Official Title: Clinical Evaluation of Silicone Gel in the Treatment of Cleft Lip Scars
Actual Study Start Date : January 28, 2014
Actual Primary Completion Date : November 29, 2016
Actual Study Completion Date : October 12, 2017

Resource links provided by the National Library of Medicine


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 Name: Dermatix Ultra




Primary Outcome Measures :
  1. 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


  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314090


Locations
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Taiwan
Chang Chun Shin
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital

Publications:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03314090    
Other Study ID Numbers: 102-4719b
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Chang Gung Memorial Hospital:
Cleft lip
Scar
Silicone sheet
Silicone gel
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities