A. B. Hesselvig, Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark; Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte, Denmark.
M. Arpi, Department of Clinical Microbiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Clin Orthop Relat Res. 2020 May;478(5):1007-1015. doi: 10.1097/CORR.0000000000001142.
The risk of periprosthetic joint infection (PJI), a serious complication after arthroplasty, has not changed for years. Interventions such as eradication of Staphylococcus aureus and antibiotic bone cement are used to diminish infection risk but despite these efforts, the percentage of infection in TKA remains constant. Antimicrobial drapes have a dual action, acting both as a physical and antimicrobial barrier to counter bacterial contamination of the surgical wound. To study the effect of antimicrobial drapes, we used intraoperative contamination as a proxy for infection in our investigation.
QUESTIONS/PURPOSES: (1) Do antimicrobial surgical drapes reduce the risk of intraoperative microbial contamination in patients undergoing primary knee arthroplasty? (2) Are other factors such as sex, season, age, type of arthroplasty and duration of surgery associated with an increased risk of contamination in patients undergoing primary knee arthroplasty? (3) Does loosening of the antimicrobial drape increase contamination risk?
An investigator-initiated, two-arm, non-blinded, multicenter, randomized, controlled trial was performed at five different hospitals in the capital and central regions of Denmark. Twenty-four surgeons participated in the study. Participants were patients older than 18 years undergoing primary knee arthroplasty. We excluded patients with an iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken 4 weeks before surgery, and if they were unable to understand the implications of study participation. Patients were randomly assigned to operation with an antimicrobial drape (intervention group) or operation without (control group). We screened 1769 patients, of which 100 were ineligible and 10 declined to participate. In all, 94% (1659 of 1769) of patients consented and were randomized to the intervention group (51%, 838 of 1659) and control group (49%, 821 of 1659), respectively. In all, 36% (603 of 1659) of patients in the intervention group and 35% (584 of 1659) patients in the control group were available for final analysis. No crossover was performed, and analysis was done per-protocol. Patients were excluded due to logistic failures like lack of utensils, samples disappearing en route to the laboratory mainly caused by implementation of a new electronic patient chart (EPIC, Verona, WI, USA), and forgetful surgeons. Intraoperatively, we swabbed for bacteria at the surgical site and in a rinse from the surgeons' gloves. All samples were sent for cultivation, and colony forming units (CFUs) counts ≥ 1 were deemed contaminated. The primary outcome measure was the difference in the proportion of contaminated patients between the two randomized groups. Secondary outcome measures were the affiliation of sex, season, age, type of implant used, and duration of surgery on contamination risk. To investigate whether other factors were affiliated with contamination risk, we did a logistic regression to control for confounding variables, including sex, age, season, type of implant and duration of surgery.
Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients. After controlling for confounding variables such as sex, age, type of implant, and duration of surgery, we found that not using an antimicrobial drape increased contamination risk by a factor of 1.6 (95% CI 1.08 to 2.35; p = 0.02). Female sex and undergoing surgery in the central region were associated with lower odds of contamination (OR 0.55 [95% CI 0.39 to 0.8]; p = 0.002 and OR 0.45 [95% CI 0.25 to 0.8]; p = 0.006, respectively). Patients with more than a 10-mm separation of the drape from the skin had higher odds of contamination (OR 3.54 [95% CI 1.64 to 11.05]; p = 0.0013).
The use of an antimicrobial drape resulted in lower contamination risk than operating without an antimicrobial drape. Our findings suggest that antimicrobial drapes are useful in infection prevention, but further studies are needed to investigate the effect of antimicrobial drapes on infection.
Level I, therapeutic study.
关节置换术后假体周围关节感染（PJI）是一种严重的并发症，其风险多年来并未改变。为了降低感染风险，人们采用了清除金黄色葡萄球菌和抗生素骨水泥等干预措施，但尽管采取了这些措施，全膝关节置换术（TKA）中的感染率仍保持不变。抗菌手术铺巾具有双重作用，既能作为物理屏障，也能作为抗菌屏障，防止手术伤口的细菌污染。为了研究抗菌手术铺巾的效果，我们将术中污染作为感染的替代指标来进行调查。
问题/目的：（1）在接受初次膝关节置换术的患者中，使用抗菌手术铺巾是否会降低术中微生物污染的风险？（2）性别、季节、年龄、关节置换类型和手术时间等其他因素是否会增加初次膝关节置换术患者的污染风险？（3）抗菌铺巾松动是否会增加污染风险？
在丹麦首都和中心地区的五家不同医院进行了一项由研究者发起的、双盲、非随机、多中心、对照临床试验。共有 24 名外科医生参与了这项研究。参与者为年龄大于 18 岁、接受初次膝关节置换术的患者。我们排除了对碘过敏、有过开放膝关节手术史、有过化脓性关节炎、术前 4 周内服用过任何抗生素以及无法理解研究参与意义的患者。患者被随机分配到使用抗菌铺巾（干预组）或不使用（对照组）的手术中。我们筛查了 1769 名患者，其中 100 名不符合条件，10 名患者拒绝参与。共有 94%（1659/1769）的患者同意并被随机分配到干预组（51%，838/1659）和对照组（49%，821/1659）。在干预组和对照组中，分别有 36%（603/1659）和 35%（584/1659）的患者最终可用于分析。未进行交叉，且分析按照方案进行。由于器械缺乏、样本在送往实验室的途中丢失（主要是由于实施了新的电子病历系统（EPIC，Verona，WI，USA））和健忘的外科医生等逻辑故障，患者被排除在外。术中，我们在手术部位和外科医生手套的冲洗液中拭取细菌样本。所有样本均送检培养，菌落形成单位（CFU）计数≥1 被视为污染。主要观察指标是两组随机患者中污染患者的比例差异。次要观察指标是性别、季节、年龄、植入物类型和手术时间对污染风险的影响。为了研究是否有其他因素与污染风险有关，我们进行了逻辑回归分析，以控制混杂变量，包括性别、年龄、季节、植入物类型和手术时间。
使用含碘铺巾可降低污染风险，与未使用含碘铺巾相比，使用含碘铺巾的患者中污染的比例为 10%（60/603），而未使用含碘铺巾的患者中污染的比例为 15%（90/584）（比值比 0.61 [95%可信区间 0.43 至 0.87]；p = 0.005），相对风险降低 35%（95%可信区间 12.3 至 52.5），需要治疗的患者数为 18 例。在控制性别、年龄、植入物类型和手术时间等混杂变量后，我们发现不使用抗菌铺巾会使污染风险增加 1.6 倍（95%可信区间 1.08 至 2.35；p = 0.02）。女性和在中心地区手术与较低的污染几率相关（比值比 0.55 [95%可信区间 0.39 至 0.8]；p = 0.002 和比值比 0.45 [95%可信区间 0.25 至 0.8]；p = 0.006）。铺巾与皮肤之间的距离超过 10 毫米的患者，污染的几率更高（比值比 3.54 [95%可信区间 1.64 至 11.05]；p = 0.0013）。
使用抗菌铺巾比不使用抗菌铺巾可降低污染风险。我们的研究结果表明，抗菌铺巾在预防感染方面是有用的，但仍需要进一步研究来探讨抗菌铺巾对感染的影响。
一级，治疗性研究。
