An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)

Phase 4

• Conditions: Hypertrophic Cicatrix
• Interventions: Other: no treatment; Device: silicone gel

• Registration Number: NCT01004536
• Lead Sponsor: Samsung Medical Center

Brief Summary

Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.

Detailed Description

Prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. One day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. Subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. Obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. Sample size calculation as well as statistical analysis will be conducted by a designated statistician. Study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.

Study Timeline

• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Study Start: 2010-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-13
• Primary Completion: 2011-02
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

• Pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy
• Those who understand and agree on the trial conditions

Exclusion Criteria

• Keloid (by present and past medical history)
• Secondary infection, and/or dermatitis in and around c/s wound
• Hypersensitivity to the study agent
• Diabetes
• (Pre)eclampsia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no treatment	no treatment	The other half of cesarean section wound that is to be left untreated.
silicone gel	silicone gel	Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel

Primary Outcome Measures

Name	Time	Method
summation of scar scores of modified Vancouver Scar Scale	week 12

Secondary Outcome Measures

Name	Time	Method
summation of scar scores of mVSS 4 and 8 weeks after application	weeks 4, 8, 12
scar thickness 12 weeks after application	weeks 4, 8, 12
subjective satisfaction 12 weeks after application (VAS)	weeks 4, 8, 12
tolerability 4, 8, 12 weeks after application (index3)	weeks 4, 8, 12

Trial Locations

Locations (3)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung-Hee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of