Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX 77030, USA.
N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
Since the patient's skin is a major source of pathogens that cause surgical-site infection, optimization of preoperative skin antisepsis may decrease postoperative infections. We hypothesized that preoperative skin cleansing with chlorhexidine-alcohol is more protective against infection than is povidone-iodine.
We randomly assigned adults undergoing clean-contaminated surgery in six hospitals to preoperative skin preparation with either chlorhexidine-alcohol scrub or povidone-iodine scrub and paint. The primary outcome was any surgical-site infection within 30 days after surgery. Secondary outcomes included individual types of surgical-site infections.
A total of 849 subjects (409 in the chlorhexidine-alcohol group and 440 in the povidone-iodine group) qualified for the intention-to-treat analysis. The overall rate of surgical-site infection was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group (9.5% vs. 16.1%; P=0.004; relative risk, 0.59; 95% confidence interval, 0.41 to 0.85). Chlorhexidine-alcohol was significantly more protective than povidone-iodine against both superficial incisional infections (4.2% vs. 8.6%, P=0.008) and deep incisional infections (1% vs. 3%, P=0.05) but not against organ-space infections (4.4% vs. 4.5%). Similar results were observed in the per-protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period. Adverse events were similar in the two study groups.
Preoperative cleansing of the patient's skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection after clean-contaminated surgery. (ClinicalTrials.gov number, NCT00290290.)
由于患者的皮肤是导致手术部位感染的主要病原体来源,因此优化术前皮肤消毒可能会降低术后感染的风险。我们假设,与聚维酮碘相比,用洗必泰-酒精进行术前皮肤清洁更能预防感染。
我们将六家医院中接受清洁污染手术的成年人随机分配到使用洗必泰酒精擦洗或聚维酮碘擦洗和涂抹的术前皮肤准备组。主要结果是术后 30 天内任何手术部位的感染。次要结果包括手术部位感染的各个类型。
共有 849 名受试者(洗必泰酒精组 409 名,聚维酮碘组 440 名)符合意向治疗分析的条件。洗必泰酒精组的手术部位感染总发生率明显低于聚维酮碘组(9.5%比 16.1%;P=0.004;相对风险,0.59;95%置信区间,0.41 至 0.85)。洗必泰酒精在预防浅表切口感染(4.2%比 8.6%,P=0.008)和深部切口感染(1%比 3%,P=0.05)方面明显优于聚维酮碘,但在预防器官间隙感染方面没有差异(4.4%比 4.5%)。在 30 天随访期间仍留在研究中的 813 名患者的方案分析中也观察到了类似的结果。两组研究中不良反应相似。
与聚维酮碘相比,用洗必泰-酒精清洁患者皮肤在预防清洁污染手术后的手术部位感染方面更优。(临床试验.gov 编号,NCT00290290。)