Effectiveness of Silicone Material Inserts Within Pressure Garments in the Treatment of Hypertrophic Burn Scars
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Scar pliability measured in gm/mm squared
研究概览
简要总结
The purpose of this study is to determine if the use of silicone material inserts within pressure garments is effective in decreasing hypertrophic burn scar formation as compared to standard pressure garment therapy.
详细描述
Surgical revision, potential hospitalization, and extensive post-surgical rehabilitation may be required for the revision and correction of hypertrophic burn scars to restore function and prevent disability. This in turn results in an increased financial burden to the medical system. More importantly, the patient is required to undergo an additional invasive medical procedure that can potentially create further hypertrophic scarring.
Prevention and reduction of hypertrophic scars with non-invasive, cost effective, and evidence based treatment modalities is therefore the most desirable approach. Two of the most generally accepted methods of non-invasive treatment, pressure garments and silicone gel sheeting, have been demonstrated to individually treat hypertrophic scarring. Recently, burn therapists have begun to use silicone bonded material inserts within pressure garments following the logical deduction that the two therapeutic techniques can be combined to resolve many of the cited individual disadvantages, while reaping the benefits of each individual modality. It is the aim of this study to determine the efficacy of these silicone bonded material inserts within pressure garments in the treatment of hypertrophic scarring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who would normally receive pressure garments
- •presence of an acute burn to an upper or lower extremity that requires treatment with a sheet or meshed graft
- •Minimum 4% total body surface area graft dimension (this must include areas above and below the elbow or on medial and lateral aspects of the calf
- •Between 16 years and 60 years of age
- •Patient must consent to the study or obtain consent from guardian if <18 years of age
- •Must be available for follow-up at 1 month, 3 months, 6 months, and 12 months post initiation of treatment
排除标准
- •Presence of pre-existing hypertrophic or keloid scarring
- •Pressure garments initiated greater than 2 months post discharge from hospital
- •Pre-existing decrease in range of motion of affected extremity
- •One treatment area with a prolonged healing phase or which had been treated differently in comparison to adjacent treatment area
- •Patient unable to comprehend or participate in self reporting
结局指标
主要结局
Scar pliability measured in gm/mm squared
时间窗: A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.
The Modified Vancouver Scar Scale (MVSS) will be used to measure the scar pliability. It is a therapist-judged hand held tool that measure scar properties on an ordinal scale. Because the MVSS is a subjective rating system, we will also be using the NK Skin Compliance Device (SCD)to measure scar pliability. It is a non-invasive hand-held device that measures skin compliance or pliability.
次要结局
- Scar vascularity(A baseline evaluation will be performed at the time of initial pressure garment fitting, and follow up evaluations will take place at 1 month, 3 months, 6 months and 12 months after pressure garment fitting.)
研究者
Sara-Jane Milne
Occupational Therapist
University of Manitoba