Clinical trial NCT01078428: Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
Official title: Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keloids
Hypertrophic Scars
Keywords: Hypertrophic scars
Topical silicone gel
Scar thickness
Scar Color
Scar pliability
Scar appearance
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Keloids and hypertrophic scars are a common subject of dermatologic consultations. Therapeutic management of such conditions remains challenging because of their high rate of recurrence and lack of curative treatment.

Detailed description: Silicone gel Sheeting (SGS) is one treatment modality that has proven effective for treatment of hypertrophic scar. One disadvantage of SGS is its application technique. To be effective, SGS must be applied on the scar for at least 12 hours daily. Topical silicone gel is a novel therapy that has shown promising result on scar prevention. However, the efficacy and safety of topical silicone gel for treatment of hypertrophic scar has not been confirmed.

Eligibility criteria: Inclusion Criteria:

* subjects at least 18 years old
* subjects with hypertrophic abdominal scar
* Have not received treatment on the scar at least 1 month prior to the enrollment.

Exclusion Criteria:

* subject who has previous history of silicone allergy
* subject who smoke cigarette
* subject who was treated with x-rays irradiation in the past

Primary outcomes:
measure: Scar thickness
timeFrame: 1, 2 and 5 months after initiation of treatment
Secondary outcomes:
measure: Clinical assessment on overall scar appearance
timeFrame: 1, 2 and 5 months after initiation of treatment
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Woraphong - Manuskiatti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kloeters O, Tandara A, Mustoe TA. Hypertrophic scar model in the rabbit ear: a reproducible model for studying scar tissue behavior with new observations on silicone gel sheeting for scar reduction. Wound Repair Regen. 2007 Sep-Oct;15 Suppl 1:S40-5. doi: 10.1111/j.1524-475X.2007.00224.x.
citation: Murison M, James W. Preliminary evaluation of the efficacy of dermatix silicone gel in the reduction of scar elevation and pigmentation. J Plast Reconstr Aesthet Surg. 2006;59(4):437-9. doi: 10.1016/j.bjps.2005.09.037. No abstract available.
citation: Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Plast Reconstr Surg. 2005 Sep 15;116(4):1013-20; discussion 1021-2. doi: 10.1097/01.prs.0000178397.05852.ce.
citation: Li-Tsang CW, Lau JC, Choi J, Chan CC, Jianan L. A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population. Burns. 2006 Sep;32(6):678-83. doi: 10.1016/j.burns.2006.01.016. Epub 2006 Jul 11.