A Prospective Double-Blind Randomized Clinical Trial Comparing Tap Water Irrigation With Normal Saline for Wound Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Wound Infection at 48 hours
研究概览
简要总结
This study is designed to compare the infection rates in wounds irrigated with sterile normal saline to those irrigated with chlorinated tap water. The hypothesis is that the wound infection rate subsequent to irrigation with tap water is not significantly different than the infection rate for wounds irrigated with sterile normal saline.
Inclusion criteria are patients older than 1-year of age who present to the emergency department with a soft-tissue laceration requiring repair. Exclusion criteria include patients with any underlying immunocompromising illness, current use of antibiotics, puncture or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.
Patients are randomized to have their wounds irrigated either with tap water or sterile normal saline prior to closure, controlling for the volume and irrigation method used. Structured follow-up is completed at 48 hours and 30 days to determine the presence of infection.
The primary outcome measure is the difference in wound infection rates between the two randomized groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.
排除标准
- •Diabetes mellitus
- •Asplenism
- •primary immune disorder
- •Mechanical heart valve
- •Chronic alcoholism
- •Steroid use,
- •Antibiotics use
- •Immunosuppressive chemotherapy
- •Wounds older than 9 hours or from a human or animal bite
- •Puncture wounds
- •Wounds associated with bone, tendon, or neurovascular injury
结局指标
主要结局
Wound Infection at 48 hours
时间窗: 48 hours
The primary outcome for this study is the difference in wound infection rates between the two randomized groups. It is assessed at 48 hours
次要结局
- wound infection manifest at 30 days(30 days)