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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSCP & SPMS | Experimental | The smart scar care pad (SCCP): The SCCP is a newly invented insert material that can maximise treatment outcomes via enhanced compression and occlusion. The wearing regime for SCCP is 4 hours a day for the first day, with 2-hour increments added every other day until the total wearing time reached 23 hours. SSCP was cleaned twice a day for hygienic reasons. The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering. |
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| SPMS | Active Comparator | The smart pressure monitored suit(SPMS): The SPMS is a type of custom-made pressure garment. SPMS was used 23 hours a day and only removed when showering. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSCP | Other | Insert |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Scar Pliability measured by the DermaLab Combo | Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo | baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Scar Thickness measured by the diagnostic ultrasound system | Scar thickness is measured by the diagnostic ultrasound system | baseline and 6 weeks |
| Change of Scar Pigmentation measured by the DermaLab Combo |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018807 | Polymorphism, Single-Stranded Conformational |
| ID | Term |
|---|---|
| D011110 | Polymorphism, Genetic |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
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The subjects and the analyser of the data were blinded.
| SPMS | Other | Pressure therapy |
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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.
| baseline and 6 weeks |
| Change of Scar Vascularity measured by the DermaLab Combo | 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. | baseline and 6 weeks |
| Occurrence of blistering | Occurence of blistering is observed and reported by research staff | up to 6 weeks |
| Occurrence of skin breakdown | Occurence of skin breakdown is observed and reported by research staff | up to 6 weeks |
| Occurrence of rash | Occurence of rash is observed and reported by research staff | up to 6 weeks |