Study of the Possible Improvement in Level of Sequela and Amputation/Amputation Level After Frost Injury by the Adjuvant Treatment of Hyperbaric Oxygen.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.
研究概览
简要总结
The aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage.
The investigators hope to include at least 20 patients in a randomized manner. Half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment.
Under hypotheses: The number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. The functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frost damage grade II-IV. Inclusion is needed within 48 hours from time of damage.
排除标准
- •Pregnancy. Ventilator treatment. Problems with equalizing. High grade heart failure. Chronic obstructive lung disease of high grade. Treatment over 3 days after time of damage. Serious claustrophobia/psychiatric illness.
结局指标
主要结局
Hyperbaric oxygen treatment is favorable for tissue regeneration after frost injury.
时间窗: From incusion of a patiant through a follow up after 1 year.
次要结局
- First: The number of surgeries is reduced with hyperbaric oxygen treatment.(One year from the enrollment of a patient.)
研究者
Helle Midtgaard
Physiscian
Oslo University Hospital