Overview

This trial is active, not recruiting.

Condition hypertrophic cicatrix
Treatments silicone gel, no treatment
Phase phase 4
Sponsor Samsung Medical Center
Collaborator Seoul National University Hospital
Start date October 2010
End date February 2011
Trial size 47 participants
Trial identifier NCT01004536, 2009-08-092

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
The other half of cesarean section wound that is to be left untreated.
no treatment
left untreated during the study period
(Experimental)
Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel
silicone gel Dermatix
twice daily application onto designated half of cesarean section wound for 12 weeks

Primary Outcomes

Measure
summation of scar scores of modified Vancouver Scar Scale
time frame: week 12

Secondary Outcomes

Measure
summation of scar scores of mVSS 4 and 8 weeks after application
time frame: weeks 4, 8, 12
scar thickness 12 weeks after application
time frame: weeks 4, 8, 12
subjective satisfaction 12 weeks after application (VAS)
time frame: weeks 4, 8, 12
tolerability 4, 8, 12 weeks after application (index3)
time frame: weeks 4, 8, 12

Eligibility Criteria

Female participants from 20 years up to 45 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Samsung Medical Center.