Abstract
Background: Catheter associated urinary tract infection (CAUTI) remains the most important dilemma in hospital acquired infections (HAIs), which is still unresolved. We aimed to introduce a physical antimicrobial method to reduce the risk of CAUTI. Methods: In this multicenter, randomized, double-blind study, we enrolled adults who suffered from acute urinary retention (AUR) and required catheterization in 13 hospitals in China. Participants were randomly allocated 1:1 according to a random number table to receive JUC spray dressing or placebo (normal saline, NS). Urine samples and catheter samples were collected after catheterization by trial staff for further investigation. Results: Between April, 2012 and April, 2014, 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 that of the placebo group (P < 0.01). Another 30 patients were recruited to evaluate the biofilm formation (10 groups, n=3 in each group) on catheters in catheterized patients. Scanning electronic microscope (SEM) results demonstrated that in the placebo group, bacterial biofilm was formed on day 5, and in JUC group, no bacterial biofilm was formed on day 5. Conclusion: Bacterial biofilm formation on catheters implanted in patients was confirmed for the first time and JUC spray dressing could significantly decrease the incidence of CAUTI by forming a layer of physical antimicrobial film to prevent bacterial biofilm formation on the catheters, which provides an innovative approach for controlling CAUTI. Funding Statement: National Natural Science Foundation of China. Declaration of Interest: We have no conflicts of interest to disclose. Ethical Approval Statement: The trial was approved by the Chinese Ethics Committee of Registering Clinical Trials (approval No. ChiECRCT-2012021), registered at the Chinese Clinical Trial Registry (Registration No. ChiCTR-TRC-12002562) and conducted in accordance with the latest version of the Declaration of Helsinki after all participants signed informed consent.
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