Anthony Thomas, Murray Bryce W, Sum-Ping John T, Lenkovsky Fima, Vornik Vadim D, Parker Betty J, McFarlin Jackie E, Hartless Kathleen, Huerta Sergio
Department of Surgical Services, Veterans Affairs North Texas Health Care System, 4500 S. Lancaster Road, Dallas, TX 75216, USA.
Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
To determine if an evidence-based practice bundle would result in a significantly lower rate of surgical site infections (SSIs) when compared with standard practice.
Single-institution, randomized controlled trial with blinded assessment of main outcome. The trial opened in April 2007 and was closed in January 2010.
Veterans Administration teaching hospital.
Patients who required elective transabdominal colorectal surgery were eligible. A total of 241 subjects were approached, 211 subjects were randomly allocated to 1 of 2 interventions, and 197 were included in an intention-to-treat analysis.
Subjects received either a combination of 5 evidenced-based practices (extended arm) or were treated according to our current practice (standard arm). The interventions in the extended arm included (1) omission of mechanical bowel preparation; (2) preoperative and intraoperative warming; (3) supplemental oxygen during and immediately after surgery; (4) intraoperative intravenous fluid restriction; and (5) use of a surgical wound protector.
Overall SSI rate at 30 days assessed by blinded infection control coordinators using standardized definitions.
The overall rate of SSI was 45% in the extended arm of the study and 24% in the standard arm (P = .003). Most of the increased number of infections in the extended arm were superficial incisional SSIs (36% extended arm vs 19% standard arm; P = .004). Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk (95% confidence interval, 1.36-4.56; P = .003) independent of other factors traditionally associated with SSI.
An evidence-based intervention bundle did not reduce SSIs. The bundling of interventions, even when the constituent interventions have been individually tested, does not have a predictable effect on outcome. Formal testing of bundled approaches should occur prior to implementation.
确定与标准治疗相比，循证实践组合是否会显著降低手术部位感染（SSI）率。
单机构、随机对照试验，对主要结局进行盲法评估。该试验于2007年4月开始，2010年1月结束。
退伍军人管理局教学医院。
需要择期经腹结直肠手术的患者符合条件。共纳入241名受试者，211名受试者被随机分配至2种干预措施中的1种，197名受试者纳入意向性分析。
受试者接受5种循证实践的组合（强化组）或按照我们当前的治疗方法进行治疗（标准组）。强化组的干预措施包括：（1）不进行机械肠道准备；（2）术前及术中保暖；（3）手术期间及术后即刻补充氧气；（4）术中静脉输液限制；（5）使用手术伤口保护器。
由盲法感染控制协调员使用标准化定义评估30天时的总体SSI率。
研究强化组的总体SSI率为45%，标准组为24%（P = .003）。强化组感染增加的病例多数为表浅切口SSI（强化组36% vs标准组19%；P = .004）。多变量分析表明，分配至试验强化组会带来2.49倍的风险（95%置信区间，1.36 - 4.56；P = .003），且独立于其他传统上与SSI相关的因素。
循证干预组合并未降低SSI。干预措施的组合，即使其组成干预措施已单独进行过测试，对结局也没有可预测的影响。在实施之前应进行组合方法的正式测试。
