Effectiveness of a Combined Adequate Pressure and Silicone Intervention in Comparison With Conventional Pressure Therapy for Hypertrophic Scar Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 主要终点
- Change from baseline HS thickness at 6 months
研究概览
简要总结
Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatments HS, yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + Smart Pressure Monitored Suit (SPMS) versus conventional Pressure Garment (PG in the management of severe HS in adult. It is hypothesized that the combination of adequate pressure therapy and silicone gel sheeting will demonstrate its superiority in improving scar parameters than conventional pressure garment therapy.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The ultrasound data will be processed and the data will be analysed by analysts who are blinded.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Vancouver Scar Scale (VSS) will be used to screen candidates for the study.10 Isolated scars with a total score of 4 or higher and the score of each item equal to or greater than 1 will be included.
- •The scar size should also reach 2*2 cm2 or above to allow adequate area for assessment tool attachement.
- •Consenting adult's age between 19 to 60 years old who is able to provide written consent, cooperative, and good compliance with treatment.
排除标准
- •the HS area have an open wound or infection;
- •the HS have been treated with steroid injections or other intervention (such as traditional Chinese medicine or laser therapy) prior to the study;
- •the patients have a medical condition that might affect wound healing (e.g., diabetes mellitus or another serious medical problem);
- •the patients with comorbidities that might affect their compliance to treatment: such as severe scar contracture at adjacent area that might be scheduled for reconstructive surgery.
研究组 & 干预措施
SSCP + SPMS
干预措施: compression (Device)
SSCP + SPMS
干预措施: occlusion (Device)
PG
干预措施: compression (Device)
结局指标
主要结局
Change from baseline HS thickness at 6 months
时间窗: at baseline, one and six month after treatment
HS thickness measured by the Diagnostic Ultrasound System
次要结局
- Change from baseline HS pliability at 6 months(at baseline, one and six month after treatment)
- Change from baseline HS hydration at 6 months(at baseline, one and six month after treatment)
- Change from baseline HS color at 6 months(at baseline, one and six month after treatment)
- Itchiness(at baseline, one and six month after treatment)
- QoL(at baseline, one and six month after treatment)