Gouveia Kyle, Bzovsky Sofia, O'Hara Nathan N, Phillips Mark, Thabane Lehana, Jeray Kyle J, Reilly Rachel M, Bhandari Mohit, Slobogean Gerard P, Sprague Sheila
Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
J Bone Joint Surg Am. 2025 Jun 18;107(Suppl 1):4-11. doi: 10.2106/JBJS.24.01244.
Skin antisepsis remains a vital component in prophylaxis against surgical site infection (SSI); however, for open fractures, it is unclear whether alcohol-based or aqueous solutions should be preferred. The purpose of this study was to compare the use of alcohol-based and aqueous skin antisepsis solutions, using data from the 2 PREP-IT trials, with respect to the risks of SSI and unplanned reoperation following surgery for an open fracture.
Individual patient data from the 2 cluster-randomized, crossover clinical trials were combined to create a single data set of patients undergoing surgery for an open fracture. A regression model was used to analyze the effects of an alcohol-based versus an aqueous solution, as well as for potential interaction with the use of chlorhexidine or iodine as the primary agent. The primary outcome was SSI within 90 days.
A total of 3,338 participants undergoing surgery for an open fracture were included in the final analysis, with 1,700 receiving an alcohol-based solution and 1,638 receiving an aqueous solution. Overall, the use of an alcohol-based skin antiseptic solution, compared with an aqueous solution, did not reduce the risk of SSI at 90 days (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.66 to 1.48; p = 0.95), or the risk of unplanned reoperation at 1 year (OR, 0.98; 95% CI, 0.75 to 1.28; p = 0.88). Planned subgroup analyses also found no significant difference in the risk of SSI or unplanned reoperation when participants were stratified by Gustilo-Anderson type, fracture location, or the primary ingredient of the skin preparation solution (chlorhexidine versus iodophor).
This analysis found no difference in the risk of SSI or reoperation when comparing alcohol-based and aqueous skin preparation solutions. Furthermore, this analysis demonstrated no harm with use of an alcohol-based solution for open fractures, and the PREPARE trial found that skin preparation with 0.7% iodine povacrylex in 74% isopropyl alcohol was associated with a reduced risk of SSI for closed fractures. Given these findings, surgeons may wish to consider streamlining their policy by treating all fractures with a single skin antiseptic, 0.7% iodine povacrylex in 74% isopropyl alcohol.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
皮肤消毒仍然是预防手术部位感染（SSI）的重要组成部分；然而，对于开放性骨折，尚不清楚应优先选择酒精基溶液还是水性溶液。本研究的目的是利用两项PREP-IT试验的数据，比较酒精基和水性皮肤消毒溶液在开放性骨折手术后发生SSI和非计划再次手术风险方面的差异。
将两项整群随机交叉临床试验的个体患者数据合并，创建一个接受开放性骨折手术患者的单一数据集。使用回归模型分析酒精基溶液与水性溶液的效果，以及与使用氯己定或碘作为主要消毒剂的潜在相互作用。主要结局是90天内发生的SSI。
最终分析纳入了3338例接受开放性骨折手术的参与者，其中1700例接受酒精基溶液，1638例接受水性溶液。总体而言，与水性溶液相比，使用酒精基皮肤消毒溶液在90天时并未降低SSI风险（比值比[OR]，0.99；95%置信区间[CI]，0.66至1.48；p = 0.95），在1年时也未降低非计划再次手术风险（OR，0.98；95%CI，0.75至1.28；p = 0.88）。计划的亚组分析还发现，当按Gustilo-Anderson分型、骨折部位或皮肤准备溶液的主要成分（氯己定与碘伏）对参与者进行分层时，SSI风险或非计划再次手术风险没有显著差异。
该分析发现，比较酒精基和水性皮肤准备溶液时，SSI风险或再次手术风险没有差异。此外，该分析表明酒精基溶液用于开放性骨折并无危害，并且PREPARE试验发现，用74%异丙醇中的0.7%聚维酮碘进行皮肤准备与降低闭合性骨折的SSI风险相关。鉴于这些发现，外科医生可能希望考虑简化其策略，对所有骨折均使用单一皮肤消毒剂，即74%异丙醇中的0.7%聚维酮碘。
治疗性III级。有关证据水平的完整描述，请参阅作者指南。
