Silicone Gel in the Treatment of Cleft Lip Scars

NCT03314090 | Completed Phase 3 DMC

• 1 other identifier: 102-4719b
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip

Keywords

Cleft lip; Scar; Silicone sheet; Silicone gel

Outcome Measures

Primary Outcomes (3)

• Vacouver scar scale

  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

  VAS with 10 grades: 0 represented the worst possible scar outcome and 10 the best possible scar outcome.

  Six months after surgery

• Scar width

  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

Study Arms (1)

Silicone Gel Group

EXPERIMENTAL

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

Interventions

Silicone Gels DRUG

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

Also known as: Dermatix Ultra

Silicone Gel Group

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• presence of other craniofacial anomalies;
• lack of signed informed consent from the parent/guardian.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Chun Shin

Taoyuan District, 333, Taiwan

Location

Related Publications (7)

• Lin TM, Lin TY, Chou CK, Lai CS, Lin SD. Application of microautologous fat transplantation in the correction of sunken upper eyelid. Plast Reconstr Surg Glob Open. 2014 Dec 5;2(11):e259. doi: 10.1097/GOX.0000000000000141. eCollection 2014 Nov.

  PMID: 25506542 BACKGROUND

• Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014.

  PMID: 25541942 BACKGROUND

• Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-516. doi: 10.1097/PRS.0000000000000416.

  PMID: 25158709 BACKGROUND

• Chernoff WG, Cramer H, Su-Huang S. The efficacy of topical silicone gel elastomers in the treatment of hypertrophic scars, keloid scars, and post-laser exfoliation erythema. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):495-500. doi: 10.1007/s00266-006-0218-1.

  PMID: 17700980 BACKGROUND

• Signorini M, Clementoni MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):183-7. doi: 10.1007/s00266-005-0122-0.

  PMID: 17171514 BACKGROUND

• Kim S, Choi TH, Liu W, Ogawa R, Suh JS, Mustoe TA. Update on scar management: guidelines for treating Asian patients. Plast Reconstr Surg. 2013 Dec;132(6):1580-1589. doi: 10.1097/PRS.0b013e3182a8070c.

  PMID: 24281584 BACKGROUND

• Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. doi: 10.1046/j.1524-475x.2002.00205.x. No abstract available.

  PMID: 12028528 BACKGROUND

MeSH Terms

Conditions

Cleft Lip; Cicatrix

Interventions

Silicone Gels

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Testing silicone gel in the treatment of upper lip scar

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 19, 2017
• Study Start: January 28, 2014
• Primary Completion: November 29, 2016
• Study Completion: October 12, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

TW (1)