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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Seoul National University Hospital
Kyunghee University Medical Center
Inovail
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01004536
First received: October 29, 2009
Last updated: December 9, 2010
Last verified: December 2010

October 29, 2009
December 9, 2010
October 2010
February 2011   (final data collection date for primary outcome measure)
summation of scar scores of modified Vancouver Scar Scale [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01004536 on ClinicalTrials.gov Archive Site
  • summation of scar scores of mVSS 4 and 8 weeks after application [ Time Frame: weeks 4, 8, 12 ] [ Designated as safety issue: Yes ]
  • scar thickness 12 weeks after application [ Time Frame: weeks 4, 8, 12 ] [ Designated as safety issue: Yes ]
  • subjective satisfaction 12 weeks after application (VAS) [ Time Frame: weeks 4, 8, 12 ] [ Designated as safety issue: Yes ]
  • tolerability 4, 8, 12 weeks after application (index3) [ Time Frame: weeks 4, 8, 12 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hypertrophic Cicatrix
  • Device: silicone gel
    twice daily application onto designated half of cesarean section wound for 12 weeks
    Other Name: Dermatix
  • Other: no treatment
    left untreated during the study period
  • No Intervention: no treatment
    The other half of cesarean section wound that is to be left untreated.
    Intervention: Other: no treatment
  • Experimental: silicone gel
    Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel
    Intervention: Device: silicone gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
47
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Female
20 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01004536
2009-08-092
No
Joo-Heung Lee, MD/professor and chair of dermatology, Samsung Medical Center
Samsung Medical Center
  • Seoul National University Hospital
  • Kyunghee University Medical Center
  • Inovail
Study Chair: Joo-Heung Lee, MD Samsung Medical Center
Samsung Medical Center
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP