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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix) in the Prevention of Hypertrophic Scar in Subjects Undergoing Caesarean Section

Conditions
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Hypertrophic Cicatrix

Intervention / Treatment
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* Device: silicone gel
* Other: no treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no treatment<br>The other half of cesarean section wound that is to be left untreated. | Other: no treatment<br>* left untreated during the study period<br>|
| Experimental: silicone gel<br>Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel | Device: silicone gel<br>* twice daily application onto designated half of cesarean section wound for 12 weeks<br>* Other names: Dermatix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| summation of scar scores of modified Vancouver Scar Scale |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |