Effectiveness of Pressure Garment Therapy After Burns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Pressure Under Compression Garment
研究概览
简要总结
Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns.
Background - Approximately one million people are burned each year in the United States. The most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that interferes with work and all other aspects of life. Pressure garment therapy is routinely used to minimize hypertrophic scarring even though there is no scientifically valid data that this therapy is efficacious. Pressure garments are extremely unattractive, expensive and uncomfortable and their use needs to be based upon valid data.
Goals and Objectives - The investigators plan to determine the effectiveness of pressure garment therapy in the control of hypertrophic scarring in healed burns.
Methods - The I-Scan® device was designed to measure pressure at the body/environment interface and allows clinicians to deal with pressure-related problems for at-risk patients. It has been widely used in rehabilitation medicine but not with burn survivors. The investigators will use this device to measure the pressure at the garment/skin interface. 2) Furthermore, the few studies that have been attempted to determine efficacy have used between subjects designs. Since burn depth is extremely variable from patient to patient and since hypertrophic scarring is greatly influenced by age and race/origin, the between subjects design requires very large numbers of subjects. The investigators will use a within wounds design studying forearm burns and applying pressure to half of the wound and no pressure to the other half. The investigators will then compare hardness, color, thickness and clinical appearance.
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 (Investigator)
入排标准
- 年龄范围
- 7 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated from time of burn at the University of Washington Burn Center during the first two years of the grant period
- •Burns covering the majority of the forearm that healed spontaneously in three or more weeks. Patients will be entered into the study within 4 weeks of injury.
- •Age 7-65 years. Patients younger than 7 years will be excluded given the cooperation required during follow-up evaluations. Patients over 65 years will be excluded since the incidence of hypertrophic scarring in persons over 65 is too low to warrant pressure garment trials.
- •Patients of any race, ethnicity, or skin color.
- •Informed, written consent in accord with the rules of the Human Subjects Committee of the University of Washington and the Health Insurance Portability and Accountability Act (HIPAA).
排除标准
- •Incarcerated patients
- •Homeless patients
- •Patients with substance abuse
- •Patients with psychiatric diagnosis
- •Patients unavailable to return regularly for follow-up evaluations
结局指标
主要结局
Pressure Under Compression Garment
时间窗: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits.
次要结局
- Durometer (Hardness) of Wound(Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5))
- Color of Wound(Approximately12 months (follow-up visits 5))
- Thickness of Wound(Approximately 12 months (follow-up visit 5))
- Clinical Appearance of Wound(Approximately 12 months (follow-up visit 5))
- Compliance With Wearing Compression Garment(About 12 months (follow-up visit 5))