Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
研究概览
简要总结
The purpose of this study is to determine whether using hyperbaric oxygen (HBO) improves wound healing for patients who have a crush injury. The comparison of the prospective intervention group to the retrospective matched cohort aims to show that HBO can improve wound healing and decrease poor outcomes for patients with crush injuries. The information gained from this small study will serve as a basis for a follow-up prospective, randomized control trial to further delineate the role of HBO in a larger patient population.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting to NYU Winthrop Hospital with a crush injury of the extremity, including appendages, up to 14 days post injury.
- •No contraindication to hyperbaric oxygen therapy.
- •Able and willing to sign informed consent.
排除标准
- •Critically-ill patient requiring intubation or pressor support.
- •Crush injury isolated to the distal phalanx (Tuft fracture).
- •Absolute contraindication to hyperbaric oxygen therapy (untreated pneumothorax). Relative contraindications (uncontrolled congestive heart failure, uncontrolled seizure disorder, pulmonary disease, claustrophobia) will be assessed by the treating physician.
- •Unable or unwilling to sign informed consent.
研究组 & 干预措施
Standard of Care without HBO
Intravenous access and fluid resuscitation (standard of care treatment)
干预措施: Standard of Care (Other)
HBO + Standard of Care
Ten daily treatment sessions of HBO at 2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks
干预措施: HBO (Procedure)
HBO + Standard of Care
Ten daily treatment sessions of HBO at 2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks
干预措施: Standard of Care (Other)
结局指标
主要结局
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
时间窗: week 52
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
时间窗: week 2
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
时间窗: week 6
healing measured by percentage of skin necrosis using a Bilateral Perfusion Index (BPI; TCOM of the affected limb/TCOM of the nonaffected limb).
时间窗: week 24
次要结局
- hospital length of stay(52 Weeks)