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

Primary Purpose

Keloids, Hypertrophic Scars

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Topical silicone gel

Vaseline

About this trial

This is an interventional treatment trial for Keloids focused on measuring Hypertrophic scars, Topical silicone gel, Scar thickness, Scar Color, Scar pliability, Scar appearance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Silicone gel

Vaseline

Arm Description

Gel containing silicone gel

Gel containing petrolatum gel

Outcomes

Primary Outcome Measures

Scar thickness

Secondary Outcome Measures

Clinical assessment on overall scar appearance

Full Information

NCT ID

NCT01078428

First Posted

February 27, 2010

Last Updated

January 24, 2014

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01078428

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloids, Hypertrophic Scars

Keywords

Hypertrophic scars, Topical silicone gel, Scar thickness, Scar Color, Scar pliability, Scar appearance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silicone gel

Arm Type

Active Comparator

Arm Description

Gel containing silicone gel

Arm Title

Vaseline

Arm Type

Placebo Comparator

Arm Description

Gel containing petrolatum gel

Intervention Type

Other

Intervention Name(s)

Topical silicone gel

Other Intervention Name(s)

Dermatix gel

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Vaseline

Intervention Description

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

Primary Outcome Measure Information:

Title

Scar thickness

Time Frame

1, 2 and 5 months after initiation of treatment

Secondary Outcome Measure Information:

Title

Clinical assessment on overall scar appearance

Time Frame

1, 2 and 5 months after initiation of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woraphong - Manuskiatti, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

17727466

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.

Results Reference

background

PubMed Identifier

16756266

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.

Results Reference

background

PubMed Identifier

16163087

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.

Results Reference

background

PubMed Identifier

16837136

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.

Results Reference

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

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