Does Hyperbaric Oxygen Reduce Complications and Improve Outcomes After Open Tibial Fractures With Severe Soft Tissue Injury? An International Multi-centre Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Acute phase complication rate
研究概览
简要总结
Study hypothesis :Hyperbaric Oxygen may prevent complications and improve outcomes in severe lower limb trauma. We propose to investigate this hypothesis by conducting an International multi centre randomised control trial of standard trauma/orthopaedic care with or without a concurrent course of hyperbaric oxygen treatments.
详细描述
A randomised controlled trial was undertaken on using hyperbaric oxygen in addition to standard orthopaedic trauma care in severe lower leg injury, defined as an open tibial fracture with severe soft tissue injury. The control arm subjects received standard hospital trauma care whilst the intervention group received standard trauma care with the addition of hyperbaric oxygen therapy with the aim of providing 12 HBOT sessions over the first 9 days of hospital care. The primary outcome measure was the incidence of wound necrosis AND/OR wound infection as assessed at Day 14, with secondary outcomes of wound closure, wound complications, infections and delayed bone union at 12 months plus quality of life and functional questionnaire outcomes at 12 months and 2 years.
The detailed study protocol was published in in June 2015 and the results were published in September 2022. Both publications are Open Access (See References section for publication details)
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Surgeons initially operating were unaware of allocation. Outcomes arbitrations were conducted by surgeons blind to intervention allocation. Chief investigator masked until follow up data finally received and records locked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute fracture of the tibia with significant soft tissue injury of Gustilo Grade 3
- •Enrolment within 48 hours of injury with expectation of commencement of HBO therapy within 48 hours of injury
- •Valid consent
排除标准
- •Significant head injury
- •Injuries incompatible with HBO
- •resuscitation requirements incompatible with HBO
- •follow up not possible
- •hyperbaric contra indications
结局指标
主要结局
Acute phase complication rate
时间窗: up to 14 days post trauma
The incidence of acute complications after injury. A composite measure defined as the occurrence within two weeks of trauma of one or both of: significant soft tissue necrosis developing after the initial surgery or significant wound infection.
次要结局
- Late infection(3, 6, 9, 12, 18 and 24 months post trauma)
- Wound persistence(3, 6, 9, 12, 18 and 24 months post trauma)
- Functional outcome score(3, 6, 9, 12, 18 and 24 months post trauma)
- Delayed union of fracture(12 months post trauma)
- Amputation rate(3, 6, 9, 12, 18 and 24 months post trauma)
- Radiological union(3, 6, 9, 12, 18 and 24 months post trauma)
- Quality of life score(3, 6, 9, 12, 18 and 24 months post trauma)
- Problem Wounds(12 months post trauma)
- Pain score(3, 6, 9, 12, 18 and 24 months post trauma)