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.

Study Overview

• Status: Unknown
• Conditions: Hypertrophic Cicatrix
• Intervention / Treatment: Other: no treatment; Device: silicone gel

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.

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyung-Hee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Dermatix

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Seoul National University Hospital; Kyunghee University Medical Center; Inovail
• Investigators: Study Chair: Joo-Heung Lee, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2010
• Last Update Submitted That Met QC Criteria: December 9, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Hypertrophy; Cicatrix; Cicatrix, Hypertrophic
• Other Study ID Numbers: 2009-08-092