Clinical Trial: An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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 Und
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 Summary: 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.
Sponsor: Samsung Medical Center
Current Primary Outcome: summation of scar scores of modified Vancouver Scar Scale [ Time Frame: week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- summation of scar scores of mVSS 4 and 8 weeks after application [ Time Frame: weeks 4, 8, 12 ]
- scar thickness 12 weeks after application [ Time Frame: weeks 4, 8, 12 ]
- subjective satisfaction 12 weeks after application (VAS) [ Time Frame: weeks 4, 8, 12 ]
- tolerability 4, 8, 12 weeks after application (index3) [ Time Frame: weeks 4, 8, 12 ]
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: October 29, 2009
Date Started: October 2010
Date Completion: February 2011
Last Updated: December 9, 2010
Last Verified: December 2010
