An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
Primary Purpose
Hypertrophic Cicatrix
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
silicone gel
no treatment
Sponsored by
About this trial
This is an interventional prevention trial for Hypertrophic Cicatrix
Eligibility 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
Sites / Locations
- Samsung Medical Center
- Kyung-Hee University Medical Center
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
no treatment
silicone gel
Arm Description
The other half of cesarean section wound that is to be left untreated.
Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel
Outcomes
Primary Outcome Measures
summation of scar scores of modified Vancouver Scar Scale
Secondary Outcome Measures
summation of scar scores of mVSS 4 and 8 weeks after application
scar thickness 12 weeks after application
subjective satisfaction 12 weeks after application (VAS)
tolerability 4, 8, 12 weeks after application (index3)
Full Information
NCT ID
NCT01004536
First Posted
October 29, 2009
Last Updated
December 9, 2010
Sponsor
Samsung Medical Center
Collaborators
Seoul National University Hospital, Kyunghee University Medical Center, Inovail
1. Study Identification
Unique Protocol Identification Number
NCT01004536
Brief Title
An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
Collaborators
Seoul National University Hospital, Kyunghee University Medical Center, Inovail
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cicatrix
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
The other half of cesarean section wound that is to be left untreated.
Arm Title
silicone gel
Arm Type
Experimental
Arm Description
Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel
Intervention Type
Device
Intervention Name(s)
silicone gel
Other Intervention Name(s)
Dermatix
Intervention Description
twice daily application onto designated half of cesarean section wound for 12 weeks
Intervention Type
Other
Intervention Name(s)
no treatment
Intervention Description
left untreated during the study period
Primary Outcome Measure Information:
Title
summation of scar scores of modified Vancouver Scar Scale
Time Frame
week 12
Secondary Outcome Measure Information:
Title
summation of scar scores of mVSS 4 and 8 weeks after application
Time Frame
weeks 4, 8, 12
Title
scar thickness 12 weeks after application
Time Frame
weeks 4, 8, 12
Title
subjective satisfaction 12 weeks after application (VAS)
Time Frame
weeks 4, 8, 12
Title
tolerability 4, 8, 12 weeks after application (index3)
Time Frame
weeks 4, 8, 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Heung Lee, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Kyung-Hee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
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