Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
Lanzhou University Second Hospital, No. 82, Cuiyingmen, Chengguan District, Lanzhou, 730030, People's Republic of China.
Antimicrob Resist Infect Control. 2024 Sep 2;13(1):96. doi: 10.1186/s13756-024-01450-0.
Catheter-associated urinary tract infection (CAUTI) remains the most significant challenge among hospital-acquired infections (HAIs), yet still unresolved. The present study aims to evaluate the preventive effectiveness of JUC Spray Dressing (name of U.S. FDA and CE certifications, while the medical device name in China is Long-acting Antimicrobial Material) alone for CAUTI without combining with antibiotics and to evaluate the impact of bacterial biofilm formation on CAUTI results on the inserted catheters of patients.
In this multicenter, randomized, double-blind study, we enrolled adults who suffered from acute urinary retention (AUR) and required catheterization in 6 hospitals in China. Participants were randomly allocated 1:1 according to a random number table to receive JUC Spray Dressing (JUC group) or normal saline (placebo group). The catheters were pretreated with JUC Spray Dressing or normal saline respectively before catheterization. Urine samples and catheter samples were collected after catheterization by trial staff for further investigation.
From April 2012 to April 2020, we enrolled 264 patients and randomly assigned them to the JUC group (n = 132) and the placebo group (n = 132). Clinical symptoms and urine bacterial cultures showed the incidence of CAUTI of the JUC group was significantly lower than the placebo group (P < 0.01). In addition, another 30 patients were enrolled to evaluate the biofilm formation on catheters after catheter insertion in the patients' urethra (10 groups, 3 each). The results of scanning electron microscopy (SEM) showed that bacterial biofilm formed on the 5th day in the placebo group, while no bacterial biofilm formed on the 5th day in the JUC group. In addition, no adverse reactions were reported using JUC Spray Dressing.
Continued indwelling urinary catheters for 5 days resulted in bacterial biofilm formation, and pretreatment of urethral catheters with JUC Spray Dressing can prevent bacterial biofilm formation by forming a physical antimicrobial film, and significantly reduce the incidence of CAUTI. This is the first report of a study on inhibiting bacterial biofilm formation on the catheters in CAUTI patients.
在医院获得性感染（HAI）中，导管相关性尿路感染（CAUTI）仍然是最重大的挑战，但尚未得到解决。本研究旨在评估 JUC 喷雾敷料（美国 FDA 和 CE 认证的名称，而在中国的医疗器械名称为长效抗菌材料）单独用于 CAUTI 的预防效果，而不与抗生素联合使用，并评估细菌生物膜形成对留置患者导管 CAUTI 结果的影响。
在这项多中心、随机、双盲研究中，我们招募了在中国 6 家医院因急性尿潴留（AUR）需要导尿的成年人。参与者根据随机数字表按 1:1 随机分配接受 JUC 喷雾敷料（JUC 组）或生理盐水（安慰剂组）。在导尿前，导管分别用 JUC 喷雾敷料或生理盐水预处理。试验人员在导尿后采集尿液样本和导管样本进行进一步研究。
2012 年 4 月至 2020 年 4 月，我们共招募了 264 名患者，并将其随机分为 JUC 组（n=132）和安慰剂组（n=132）。临床症状和尿液细菌培养显示 JUC 组 CAUTI 的发生率明显低于安慰剂组（P<0.01）。此外，我们还招募了另外 30 名患者评估患者尿道内留置导管后导管上生物膜的形成（10 组，每组 3 例）。扫描电子显微镜（SEM）的结果显示，安慰剂组第 5 天形成细菌生物膜，而 JUC 组第 5 天未形成细菌生物膜。此外，使用 JUC 喷雾敷料未报告不良反应。
连续留置导尿管 5 天可导致细菌生物膜形成，用 JUC 喷雾敷料预处理尿道导管可通过形成物理抗菌膜来预防细菌生物膜形成，并显著降低 CAUTI 的发生率。这是首例关于抑制 CAUTI 患者导管上细菌生物膜形成的研究报告。
