Cleft Lip Clinical Trial
Official title:
Clinical Evaluation of Silicone Gel in the Treatment of Cleft Lip Scars
Verified date | October 2017 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | October 12, 2017 |
Est. primary completion date | November 29, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 12 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Chun Shin | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. Review. — View Citation
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):511-6. doi: 10.1097/PRS.0000000000000416. — View Citation
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. — View Citation
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. — View Citation
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):1580-9. doi: 10.1097/PRS.0b013e3182a8070c. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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