Fluid Lavage of Open Wounds (FLOW): A Multi-Center, Blinded, Factorial Pilot 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
- 111
- 试验地点
- 11
- 主要终点
- The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
研究概览
简要总结
The purpose of this trial is to investigate whether irrigation solution (soap vs. saline solution), or irrigation pressure (high vs. low) will decrease the rate of infection among patients with open fracture wounds.
详细描述
Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g. high or low pressure lavage) have been described for this purpose. There are, however, a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline, as well as high versus low pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature
- •sustained an open fracture of the appendicular skeleton (type I to IIIb).
排除标准
- •vascular deficit
- •[any] allergy to detergents or castile soap
- •previous wound infection or osteomyelitis
- •previous fracture with retained hardware in the injured extremity
- •operative management more than 24 hours after injury
- •use of immunosuppressive medication within six months
- •immunological deficiency or disease conditions
- •fractures of the hands (distal to the carpus) or toes
研究组 & 干预措施
Soap solution and High pressure
Irrigation with soap solution delivered at high pressure
干预措施: Type of fluid lavage solution (Procedure)
Soap solution and High pressure
Irrigation with soap solution delivered at high pressure
干预措施: Type of fluid lavage pressure (Procedure)
Normal saline and High pressure
Irrigation with normal saline delivered at high pressure
干预措施: Type of fluid lavage solution (Procedure)
Normal saline and High pressure
Irrigation with normal saline delivered at high pressure
干预措施: Type of fluid lavage pressure (Procedure)
Normal saline and Low pressure
Irrigation with saline solution delivered at low pressure
干预措施: Type of fluid lavage solution (Procedure)
Normal saline and Low pressure
Irrigation with saline solution delivered at low pressure
干预措施: Type of fluid lavage pressure (Procedure)
Soap solution and Low pressure
Irrigation with soap solution delivered at low pressure
干预措施: Type of fluid lavage solution (Procedure)
Soap solution and Low pressure
Irrigation with soap solution delivered at low pressure
干预措施: Type of fluid lavage pressure (Procedure)
结局指标
主要结局
The Number of Participants With Re-operations (All Subsequent Operative Procedures to Treat an Infection, a Wound Healing Problem, or a Nonunion).
时间窗: one year
次要结局
- Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Solution).(1 year)
- Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the SF-12 Questionnaire (Pressure)(one year)
- The Number of Participants With All Operative and Non-operatively Managed Infections, Wound Healing Problems, and Nonunions.(1 year)
- Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Solution).(one year)
- Mean Difference in Health-related Quality of Life and Physical Function From Baseline (Pre-injury) to 12 Months Measured by the EQ-5D Questionnaire (Pressure)(one year)