Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya
Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya
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DOI：
10.1002/bjs.7213
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发表时间：
2010-11-01
影响因子：
9.6
通讯作者：
Harbarth, S.
中科院分区：
文献类型：
--
作者：
Nthumba, P. M.;Stepita-Poenaru, E.;Harbarth, S.
背景：这项整群随机、交叉试验的目的是在肯尼亚乡村医院比较普通肥皂和水与酒精类洗手液在手术手准备和预防手术部位感染 (SSI) 方面的功效。方法：总共纳入了 3317 名接受清洁手术和清洁污染手术的患者。 3133 名患者 (94.5%) 可获得出院后 30 天的随访数据。 结果：255 名患者 (8.1%) 发生 SSI，两个研究组的发生率相似：酒精类洗手液为 8.3%，普通肥皂和水为 8.0%（比值比 1.03，95% 置信区间为 0.80 至 1.33）。在对研究组之间的不平衡和聚类效应进行调整后，主要结果指标保持不变（调整后的比值比为 1.06、0.81 至 1.38）。手术持续时间和伤口污染等级独立预测 SSI。两种方法之间的成本差异很小（酒精类洗手液为每周 4.60 美元，而肥皂和水为 3.30 美元）。结论：SSI 发生率没有统计学或临床显着差异，可能是因为更重要的因素导致 SSI 发生。然而，这项研究证明了在没有持续清洁水的情况下，在手术前使用酒精类洗手液进行手部准备的可行性和经济性。注册号：NCT00987402 (http://www.clinicaltrials.gov)。
Background: The aim of this cluster-randomized, crossover trial was to compare the efficacy of plain soap and water with an alcohol-based handrub for surgical hand preparation and prevention of surgical-site infection (SSI) in a Kenyan rural hospital.Methods: A total of 3317 patients undergoing clean and clean-contaminated surgery were included. Follow-up data 30 days after discharge were available for 3133 patients (94.5 per cent).Results: SSI occurred in 255 patients (8.1 per cent), with similar rates for both study arms: 8.3 per cent for alcohol-based handrub versus 8.0 per cent for plain soap and water (odds ratio 1.03, 95 per cent confidence interval 0.80 to 1.33). After adjustment for imbalances between study arms and clustering effects, the main outcome measure remained unchanged (adjusted odds ratio 1.06, 0.81 to 1.38). The duration of surgery and wound contamination class independently predicted SSI. The cost difference between the methods was small ((sic)4.60 per week for alcohol-based handrub compared with (sic)3.30 for soap and water).Conclusion: There was no statistically or clinically significant difference in SSI rates, probably because more important factors contribute to SSI development. However, this study demonstrated the feasibility and affordability of alcohol-based handrubs for hand preparation before surgery in settings without continuous, clean water. Registration number: NCT00987402 (http://www.clinicaltrials.gov).