N/A
N=40
Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars
Hypertrophic Surgical Scar
Bottom Line
View on ClinicalTrials.gov: NCT01689857 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months — -3.80; -2.61 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scarclinic™ Thin (Device); Scarclinic™ Normal (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months |
-3.80; -2.61 | — |
| SECONDARY Satisfaction for Serviceability |
— | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01689857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.