Clinical trial NCT01004536: An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
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 Undergoing Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertrophic Cicatrix
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Kyunghee University Medical Center
name: Inovail
First posted: 2009-10-30
Enrollment: 47
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: summation of scar scores of modified Vancouver Scar Scale
timeFrame: week 12
Secondary outcomes:
measure: summation of scar scores of mVSS 4 and 8 weeks after application
timeFrame: weeks 4, 8, 12
measure: scar thickness 12 weeks after application
timeFrame: weeks 4, 8, 12
measure: subjective satisfaction 12 weeks after application (VAS)
timeFrame: weeks 4, 8, 12
measure: tolerability 4, 8, 12 weeks after application (index3)
timeFrame: weeks 4, 8, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung-Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Samsung Medical Center
name: Joo-Heung Lee, MD
role: STUDY_CHAIR
References: