The Effectiveness of a Smart Scar Care Pad and Pressure Therapy Versus Pressure Therapy in Hypertrophic Scar Management: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Change of Scar Pliability measured by the DermaLab Combo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The subjects and the analyser of the data were blinded.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
SSCP & 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.
干预措施: SSCP (Other)
SSCP & 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.
干预措施: SPMS (Other)
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.
干预措施: SPMS (Other)
结局指标
主要结局
Change of Scar Pliability measured by the DermaLab Combo
时间窗: baseline and 6 weeks
Scar pliability is represented by the Young's modulus measured by the elasticity measurement of the DermaLab Combo
次要结局
- Change of Scar Thickness measured by the diagnostic ultrasound system(baseline and 6 weeks)
- Change of Scar Pigmentation measured by the DermaLab Combo(baseline and 6 weeks)
- Change of Scar Vascularity measured by the DermaLab Combo(baseline and 6 weeks)
- Occurrence of blistering(up to 6 weeks)
- Occurrence of skin breakdown(up to 6 weeks)
- Occurrence of rash(up to 6 weeks)