Hypertrophic Surgical Scar
Conditions
Keywords
hypertropic scar, Vancouver scar scale, silicon gel sheet
Brief summary
Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars. Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number
Detailed description
For evaluating the efficacy * The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness * The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.
Interventions
DEVICEScarclinic™ Thin
Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.
DEVICEScarclinic™ Normal
Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patient who aged more than 18 years and less 55 years * Patient who has a surgical scar that is not over 3 months after the surgery * Patient who sign informed consent form for the study
Exclusion criteria
* need wound dressing for exudate * wound infection * general malaise * history of mental disorders * taking anticancer drugs or antiphlogistics or steroid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months | Baseline and 3 months | Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables. * vascularity(range from normal(0 point) to purple(3point) * pigmentation(range from normal(0 point) to hyper-pigmentation(3point) * pliability(range from normal(0 point) to contracture(5point) * height (range from flat(0 point) to above 5mm(3point) * pain(range from none(0 point) to Require medication(2point) * itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction for Serviceability | the end of the 3 month of the treatment | Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire |
Countries
South Korea
Participant flow
Recruitment details
This study was conducted at Seoul National University Bundang hospital. Forty subjects were recruited from May, 2010 to April,2012.
Pre-assignment details
In this study, we had no run-in period before study was commenced and there were no subjects who drop out before enrollment and randomization to groups.
Participants by arm
| Arm | Count |
|---|---|
| Scarclinic™ Thin Scarclinic™ Thin applied on the surgical scar for 12weeks | 20 |
| Scarclinic™ Normal Scarclinic™ Normal applied on the surgical scar for 12weeks | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 |
Baseline characteristics
| Characteristic | Scarclinic™ Normal | Scarclinic™ Thin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age Continuous | 36.00 years STANDARD_DEVIATION 9.93 | 39.90 years STANDARD_DEVIATION 10.47 | 37.95 years STANDARD_DEVIATION 10.26 |
| Region of Enrollment Korea, Republic of | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 20 | 9 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables. * vascularity(range from normal(0 point) to purple(3point) * pigmentation(range from normal(0 point) to hyper-pigmentation(3point) * pliability(range from normal(0 point) to contracture(5point) * height (range from flat(0 point) to above 5mm(3point) * pain(range from none(0 point) to Require medication(2point) * itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.
Time frame: Baseline and 3 months
Population: All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scarclinic™ Thin | Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months | -3.80 units on a scale | Standard Deviation 3.02 |
| Scarclinic™ Normal | Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months | -2.61 units on a scale | Standard Deviation 2.63 |
Secondary
Satisfaction for Serviceability
Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire
Time frame: the end of the 3 month of the treatment