Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures: The TOBRA Randomized Clinical Trial.

It is unknown whether the addition of tobramycin powder further decreases infection rates.

尚不清楚添加妥布霉素粉末是否会进一步降低感染率。

Background

To compare whether the combination of tobramycin plus vancomycin vs vancomycin alone delivered as intrawound powder at the time of definitive fixation reduces deep surgical site infections.

比较妥布霉素加万古霉素与单独使用万古霉素作为伤口内粉末在确定性固定时施用，是否能降低深部手术部位感染的发生。

DESIGN, SETTING, AND PARTICIPANTS: Open-label, assessor-masked, randomized clinical trial conducted at 39 US trauma centers.

设计、环境和参与者：在美国39个创伤中心进行的开放标签、评估者盲法的随机临床试验。

Eligible patients were adults with an operatively treated periarticular tibial fracture (either tibial plateau or pilon) who met 1 of 3 criteria for elevated infection risk.

符合条件的患者是成年患者，他们接受了手术治疗的胫骨近端关节周围骨折（包括胫骨平台或胫骨踝部骨折），并且符合3项高感染风险标准中的一项。

Enrollment occurred between June 18, 2021, and December 12, 2024 (final follow-up, July 15, 2025).

招募工作从2021年6月18日开始，至2024年12月12日结束（最终随访日期为2025年7月15日）。

Methods

Intrawound tobramycin (1.2 g) plus vancomycin (1.0 g) powder vs intrawound vancomycin (1.0 g) powder delivered at the time of definitive fixation.

在确定性固定术时，比较了创面内使用托布拉霉素（1.2克）加万古霉素（1.0克）粉末与仅使用万古霉素（1.0克）粉末的效果。

main_outcomes_and_measures

The primary outcome was a deep surgical site infection requiring surgical management within 182 days of definitive fracture fixation.

主要结果是在确定性骨折固定后182天内需要手术处理的深部手术部位感染。

Secondary outcomes included deep surgical site infections with pathogens that were gram-negative only, deep surgical site infections with at least 1 pathogen that was gram-positive, deep surgical site infections with polymicrobial cultures, deep surgical site infections with negative culture results, and cellulitis or skin infections treated only with antibiotics.

次要结果包括仅由革兰阴性病原体引起的深部手术部位感染，至少有一种病原体为革兰阳性菌的深部手术部位感染，多菌种培养的深部手术部位感染，培养结果为阴性的深部手术部位感染，以及仅用抗生素治疗的蜂窝织炎或皮肤感染。

Results

Among the 1660 participants randomized, 1528 (mean age, 47.0 [SD, 14.3] years; 603 female [39.5%]; 925 male [60.5%]) were included in the primary analysis.

在随机分配的1660名参与者中，有1528人（平均年龄47.0岁[标准差14.3]；603名女性[39.5%]；925名男性[60.5%]）被纳入主要分析。

Deep surgical site infections occurred in 51 of 753 participants (182-day probability, 7.4%) in the tobramycin plus vancomycin group and 47 of 775 participants (182-day probability, 6.6%) in the vancomycin alone group (hazard ratio, 1.11; 95% bayesian credible interval, 0.75-1.66; posterior probability of superiority, 29.7%).

在接受托布拉霉素加万古霉素治疗的753名参与者中，有51人发生了深部手术部位感染（182天概率，7.4%），而在仅接受万古霉素治疗的775名参与者中，有47人发生了深部手术部位感染（182天概率，6.6%）（风险比，1.11；95%贝叶斯可信区间，0.75-1.66；后验概率优势，29.7%）。

The threshold required for superiority was not reached for any secondary outcome.

任何次要结果的优越性阈值均未达到。

conclusions_and_relevance

Among patients with operatively treated periarticular tibial fractures at high risk of infection, adding intrawound tobramycin powder to vancomycin powder at the time of definitive fixation did not reduce deep surgical site infections compared with vancomycin powder alone.

在那些接受手术治疗且有高感染风险的关节周围胫骨骨折患者中，与单独使用万古霉素粉末相比，将万古霉素粉末与局部应用的多粘菌素B粉末结合使用，并未减少深部手术部位感染的发生。

trial_registration

ClinicalTrials.gov Identifier: NCT02227446.

ClinicalTrials.gov 注册号：NCT02227446。