Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars

NCT01078428 — Phase 4, Completed, 38 participants, Mahidol University

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Registry	NCT01078428
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, single group, masking: triple, treatment
Enrollment	38 (Actual)
Sponsor	Mahidol University (Other)
Conditions	Keloids, Hypertrophic Scars
Interventions	Topical silicone gel, Vaseline (Other)
Dates	start 2010-01-01, primary completion 2010-06-01, completion 2010-06-01, first posted 2010-03-02, last updated 2014-01-28
Locations	1 site in Thailand

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Silicone gel	Active comparator	Other: Topical silicone gel	Gel containing silicone gel
Vaseline	Placebo comparator	Other: Vaseline	Gel containing petrolatum gel

Topical silicone gel (Other), also known as Dermatix gel: Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks
Vaseline (Other): Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

+Outcome measures

Primary outcomes

Scar thickness [1, 2 and 5 months after initiation of treatment]

Secondary outcomes

Clinical assessment on overall scar appearance [1, 2 and 5 months after initiation of treatment]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine Siriraj Hospital	Bangkoknoi, Bangkok	Thailand

+Publications

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. PMID 17727466
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. PMID 16756266
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. PMID 16163087
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. PMID 16837136

+Investigators

Woraphong - Manuskiatti, M.D., Principal investigator, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University