Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,540
- 试验地点
- 55
- 主要终点
- Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
研究概览
简要总结
Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women who are skeletally mature.
- •Fracture of any extremity with complete radiographs.
- •Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)*.
- •Fracture requiring operative fixation.
- •Provision of informed consent.
排除标准
- •Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
- •Known allergy to detergents or castile soap ingredients.
- •Previous wound infection or history of osteomyelitis in the injured extremity.
- •Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
- •Surgical delay to operative wound management greater than 24 hours from hospital admission.
- •Use of immunosuppressive medication within 6 months.
- •Immunological deficient disease conditions (e.g. HIV).
- •Fracture of the hand (metacarpals and phalanges).
- •Fracture of the toes (phalanges).
- •Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
- •Previous randomization in this study or a competing study.
结局指标
主要结局
Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing.
时间窗: within 12 months
次要结局
- Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D(12 months)