Skin Wetting in Burn Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Core Temperature
研究概览
简要总结
This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering ~20% to 40% of their body surface area, and subject having burns >40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-burn survivors
- •Healthy male and female subjects
- •18-65 years of age.
- •Free of any underlying medical conditions
- •Exclusion Criteria (non-burned individuals):
- •Any burn-related injuries resulting in at least one night of hospitalization.
- •Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
- •Abnormalities detected on routine screening
- •Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
- •Current smokers, as well as individuals who regularly smoked within the past 3 years.
- •Body mass index of greater than 30 kg/m^
- •Pregnant individuals
- •Inclusion Criteria (burn survivors):
- •Healthy male and female subjects
- •18-65 years of age.
- •Free of any underlying medical conditions
- •Having a burn injury covering 20-40% or >40% of the participant's body surface area; at least 50% of those burn injuries must be full thickness that required skin grafting.
- •Participants must have been hospitalized due to the burn injury for a minimum of 15 days
- •Exclusion Criteria (burn survivors):
- •Any burn-related injuries resulting in at least one night of hospitalization.
- •Heart disease or any other chronic medical condition requiring regular medical therapy including cancer, diabetes, and hypertension.
- •Abnormalities detected on routine screening
- •Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
- •Current smokers, as well as individuals who regularly smoked within the past 3 years.
- •Body mass index of greater than 30 kg/m^
- •Pregnant individuals
- •Extensive unhealed injured skin
排除标准
- 未提供
结局指标
主要结局
Core Temperature
时间窗: Prior to and throughout the bout of exercise; an average of 90 minutes.
During exercise, one's core body temperature will increase. This device will measure this increase in core body temperature throughout the exercise.
次要结局
- Mean Skin Temperature(Prior to and throughout the bout of exercise; an average of 90 minutes.)
- Rate Pressure Product(Prior to and throughout the bout of exercise; an average of 90 minutes.)
- Whole body sweat rate(Before and after exercise. 2 min per measure.)
研究者
Craig Crandall
Professor
University of Texas Southwestern Medical Center