Cicatrix, Hypertrophic, Rehabilitation
Conditions
Keywords
insert, pressure therapy, silicone gel
Brief summary
This study explores the smart scar care pad's potential therapeutic effect in treatment hypertrophic scar while elucidating the adverse effects if there is any. Half of the participant receives traditional treatment of pressure garment and the other half receives the smart scar care pad together with pressure garment.
Interventions
Insert
Pressure therapy
Sponsors
Study design
Masking description
The subjects and the analyser of the data were blinded.
Eligibility
Inclusion criteria
1. Subjects with Hypertrophic Scar(HS); 2. the HS had a total Vancouver Scar Scale (VSS) score of 4 or higher and the score of each item equal to or greater than 1; 3. subjects age between 20 and 70 years, cooperative, and good compliance with treatment.
Exclusion criteria
1. the HS area had an open wound or infection; 2. the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or 3. the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Scar Pliability measured by the DermaLab Combo | baseline and 6 weeks | Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Scar Pigmentation measured by the DermaLab Combo | baseline and 6 weeks | Scar pigmentation is represented by the melanin score generated by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a higher melanin content. |
| Change of Scar Vascularity measured by the DermaLab Combo | baseline and 6 weeks | Scar vascularity is represented by the erythema score measured by the color probe of the DermaLab Combo. The range of the score is 0-100, where a higher score indicates a more erythematic situation. |
| Change of Scar Thickness measured by the diagnostic ultrasound system | baseline and 6 weeks | Scar thickness is measured by the diagnostic ultrasound system |
| Occurrence of skin breakdown | up to 6 weeks | Occurence of skin breakdown is observed and reported by research staff |
| Occurrence of rash | up to 6 weeks | Occurence of rash is observed and reported by research staff |
| Occurrence of blistering | up to 6 weeks | Occurence of blistering is observed and reported by research staff |