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

Hypertrophic Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078428
• Other study ID #: Si 193/2009
• Secondary ID: 125/2552(EC4)
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2010
• Last updated: January 24, 2014
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: January 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy
• Keloids

Intervention

Other:
• Topical silicone gel
Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks
• Vaseline
Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. — View 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. Erratum in: Wound Repair Regen. 2008 Jul-Aug;16(4):582. — View 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. Epub 2006 Jul 11. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar thickness		1, 2 and 5 months after initiation of treatment	Yes
Secondary	Clinical assessment on overall scar appearance		1, 2 and 5 months after initiation of treatment	Yes