The Development and Application of "Scar-care" Padding on Management of Hypertrophic Scar
- Conditions
- RehabilitationCicatrix, Hypertrophic
- Interventions
- Other: SSCPOther: SPMS
- Registration Number
- NCT03469830
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSCP & SPMS SSCP 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. SPMS SPMS 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. SSCP & SPMS SPMS 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change of Scar Thickness measured by the diagnostic ultrasound system baseline and 6 weeks Scar thickness is measured by the diagnostic ultrasound system
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.
Occurrence of blistering up to 6 weeks Occurence of blistering is observed and reported by research staff
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