The Development and Application of Scar-care Padding on Management of Hypertrophic Scar

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study

Conditions
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Cicatrix, Hypertrophic, Rehabilitation

Intervention / Treatment
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* Other: SSCP
* Other: SPMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Hypertrophic Scar(HS); 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; subjects age between 20 and 70 years, cooperative, and good compliance with treatment. Exclusion Criteria: the HS area had an open wound or infection; the HS had been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) before the study; or the patient had a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSCP & SPMS<br>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. | Other: SSCP<br>* Insert<br>* Other names: The Smart Scar Care PAd;Other: SPMS<br>* Pressure therapy<br>* Other names: The Smart Pressure Monitored Suit;|
| Active Comparator: SPMS<br>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. | Other: SPMS<br>* Pressure therapy<br>* Other names: The Smart Pressure Monitored Suit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insert, pressure therapy, silicone gel