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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertrophic Cicatrix
 Device: silicone gel
Other: no treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • summation of scar scores of modified Vancouver Scar Scale [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 47
Study Start Date: October 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no treatment
The other half of cesarean section wound that is to be left untreated.
 Other: no treatment
left untreated during the study period
Experimental: silicone gel
Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel
 Device: silicone gel
twice daily application onto designated half of cesarean section wound for 12 weeks
Other Name: Dermatix

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004536

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of
Kyung-Hee University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Seoul National University Hospital
Kyunghee University Medical Center
Inovail
Investigators
Study Chair: Joo-Heung Lee, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Joo-Heung Lee, MD/professor and chair of dermatology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01004536     History of Changes
Other Study ID Numbers: 2009-08-092
Study First Received: October 29, 2009
Last Updated: December 9, 2010
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Cicatrix
 Pathological Conditions, Anatomical
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013