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

NCT ID: NCT01078428

Last Updated: 2014-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Keloids Hypertrophic Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Silicone gel

Gel containing silicone gel

Group Type ACTIVE_COMPARATOR

Topical silicone gel

Intervention Type OTHER

Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks

Vaseline

Gel containing petrolatum gel

Group Type PLACEBO_COMPARATOR

Vaseline

Intervention Type OTHER

Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

Interventions

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Topical silicone gel

Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks

Intervention Type OTHER

Vaseline

Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

Intervention Type OTHER

Other Intervention Names

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Dermatix gel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woraphong - Manuskiatti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 17727466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16756266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16163087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16837136 (View on PubMed)

Other Identifiers

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125/2552(EC4)

Identifier Type: OTHER

Identifier Source: secondary_id

Si 193/2009

Identifier Type: -

Identifier Source: org_study_id

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