Division of Emergency Medicine, Stanford University School of Medicine, Stanford, California, USA.
BMJ Open. 2013 Jan 16;3(1):e001504. doi: 10.1136/bmjopen-2012-001504.
To determine if there is a significant difference in the infection rates of wounds irrigated with sterile normal saline (SS) versus tap water (TW), before primary wound closure.
Single centre, prospective, randomised, double-blind controlled trial. Wound irrigation solution type was computer randomised and allocation was done on a sequential basis.
Stanford University Medical Center Department of Emergency Medicine.
Patients older than 1 year of age, who presented to the emergency department with a soft tissue laceration requiring repair, were entered into the study under informed consent. Exclusion criteria included any underlying immunocompromising illness, current use of antibiotics, puncture or bite wounds, underlying tendon or bone involvement, or wounds more than 9 h old.
Non-caregivers used a computer generated randomisation code to prepare irrigation basins prior to treatment. Patients had their wounds irrigated either with TW or SS prior to closure, controlling for the volume and irrigation method used. The patient, the treating physician and the physician checking the wound for infection were all blind regarding solution type. Structured follow-up was completed at 48 h and 30 days to determine the presence of infection.
The primary outcome measured was the difference in wound infection rates between the two randomised groups.
During the 18-month study period, 663 consecutive patients were enrolled. After enrolment, 32 patients were later excluded; 29 patients because they were concurrently on antibiotics; two patients secondary to steroid use and one because of tendon involvement. Of the 631 remaining patients, 318 were randomised into the TW group and 313 into the SS group. Six patients were lost to follow-up (5 SS, 1 TW). A total of 625 patients were included in the statistical analysis. There were no differences in the demographic and clinical characteristics of the two groups. There were 20 infections 6.4% (95% CI 9.1% to 3.7%) in the SS group compared with 11 infections 3.5% (95% CI 5.5% to 1.5%) in the TW group, a difference of 2.9% (95% CI -0.4% to 5.7%).
There is no difference in the infection rate of wounds irrigated with either TW or SS solution, with a clinical trend towards fewer wound infections in the TW group, making it a safe and cost-effective alternative to SS for wound irrigation.
在初次伤口缝合前，确定用无菌生理盐水（SS）冲洗的伤口与用自来水（TW）冲洗的伤口相比，感染率是否有显著差异。
单中心、前瞻性、随机、双盲对照试验。伤口冲洗液类型由计算机随机分配，分配采用连续顺序进行。
斯坦福大学医学中心急诊医学部。
年龄大于 1 岁，因软组织撕裂伤就诊，需行修复术的患者，在知情同意的情况下入组本研究。排除标准包括任何潜在的免疫功能低下疾病、当前使用抗生素、穿刺或咬伤伤口、潜在的肌腱或骨骼受累、或伤口超过 9 小时。
非护理人员使用计算机生成的随机化代码在治疗前准备冲洗盆。患者在缝合前用 TW 或 SS 冲洗伤口，控制使用的体积和冲洗方法。患者、治疗医生和检查伤口感染的医生均对溶液类型不知情。在 48 小时和 30 天时进行了结构化随访，以确定是否存在感染。
主要观察指标是两组随机分组之间伤口感染率的差异。
在 18 个月的研究期间，连续纳入了 663 例患者。入组后，32 例患者被排除；29 例患者因同时使用抗生素；2 例患者因使用类固醇，1 例患者因肌腱受累而被排除。在剩余的 631 例患者中，318 例被随机分配到 TW 组，313 例被随机分配到 SS 组。6 例患者失访（5 例 SS，1 例 TW）。共有 625 例患者纳入统计分析。两组患者的人口统计学和临床特征无差异。SS 组有 20 例感染（6.4%[95%CI 9.1%至 3.7%]），TW 组有 11 例感染（3.5%[95%CI 5.5%至 1.5%]），差异为 2.9%（95%CI -0.4%至 5.7%）。
用 TW 或 SS 溶液冲洗的伤口感染率无差异，TW 组伤口感染率呈临床下降趋势，因此 TW 是 SS 冲洗伤口的一种安全且具有成本效益的替代方法。
