The Use of Pressure and Silicone in Children With Skin Grafts After Traumatic Skin Injury: A Randomized Control Trial for Preventative Scar Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Vancouver Scar Scale (VSS)
研究概览
简要总结
The study's objective is to compare the global scar outcomes in those treated with silicone only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
详细描述
The goals of this study are to:
- Examine the difference between patient scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the difference between observer scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the difference between Vancouver scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the need for surgical intervention in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
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
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have undergone surgery within one month prior to enrollment
- •patient must have a split-thickness or full thickness skin graft with extremity involvement secondary to a traumatic skin injury (burn, laceration, avulsion or de-gloving type injury) that has healed (based on clinician assessment of wound healing)
- •patients with comorbid conditions
- •patients must be referred to and attend scar management clinic at DCMC
排除标准
- •patients with concave scars at the site of the skin graft
- •patients with skin graft scars larger than 4x7 inches
- •patients with presence of current skin infection or history of dermatological condition such as eczema
- •patients with skin grafts only on parts of the body other than extremities
- •patients with reported silicone allergies
研究组 & 干预措施
Silicone Only Therapy (SOT)
Mepiform™ silicone will be utilized by SOT group.
干预措施: Silicone Only Therapy (SOT) (Procedure)
Silicone Pressure Garment Therapy (SPGT)
Mepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group.
干预措施: Silicone Pressure Garment Therapy (SPGT) (Procedure)
结局指标
主要结局
Vancouver Scar Scale (VSS)
时间窗: Baseline, 8 weeks, 16 weeks, and 24 weeks
This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars.
Patient Observer Scar Assessment Scale (POSAS)
时间窗: Baseline, 8 weeks, 16 weeks, and 24 weeks
This scale incorporates the patient's/caregiver's perspective on their scar. It measures scar color, pliability, thickness, relief, itching, and pain scored by patient/caregiver. The observer scale measures vascularization, pigmentation, pliability, thickness, and relief.
次要结局
- Photographs(Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24)
- Patient Compliance Log (PCL)(Baseline through 24 weeks)
- Scar Management Research Intake Form(Baseline through 24 weeks)