Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
NCT ID: NCT01078428
Last Updated: 2014-01-28
Study Results
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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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2010-01-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Silicone gel
Gel containing silicone gel
Topical silicone gel
Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks
Vaseline
Gel containing petrolatum gel
Vaseline
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
Vaseline
Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* subjects with hypertrophic abdominal scar
* Have not received treatment on the scar at least 1 month prior to the enrollment.
Exclusion Criteria
* subject who smoke cigarette
* subject who was treated with x-rays irradiation in the past
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Woraphong Manuskiatti, M.D.
Professor
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
Countries
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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.
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.
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.
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.
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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