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

Hypertrophic Cicatrix Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01004536
• Other study ID #: 2009-08-092
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 29, 2009
• Last updated: December 9, 2010
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Cicatrix
• Hypertrophy

Intervention

Device:
• silicone gel
twice daily application onto designated half of cesarean section wound for 12 weeks

Other:
• no treatment
left untreated during the study period

Locations

Country	Name	City	State
Korea, Republic of	Kyung-Hee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Samsung Medical Center	Inovail, Kyunghee University Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	summation of scar scores of modified Vancouver Scar Scale		week 12	No
Secondary	summation of scar scores of mVSS 4 and 8 weeks after application		weeks 4, 8, 12	Yes
Secondary	scar thickness 12 weeks after application		weeks 4, 8, 12	Yes
Secondary	subjective satisfaction 12 weeks after application (VAS)		weeks 4, 8, 12	Yes
Secondary	tolerability 4, 8, 12 weeks after application (index3)		weeks 4, 8, 12	Yes