Infection prevention with natural protein-based coating on the surface of Foley catheters: a randomised controlled clinical trial

Abstract

Background Health-care-associated infections characterised by antibiotic drug resistance are a global medical challenge that claims billions of dollars of health-care expenditure. Bacterial adhesion and subsequent formation of biofi lms on catheters and tubes are the primary mechanisms through which these infections are initiated and propagated. We tested the effi cacy and safety for clinical treatment of a coating based on natural protein, in which immunogenicity was eliminated through physical plasticising, applied to the surfaces of medical devices to inhibit bacterial adhesion. Methods We did a randomised clinical trial in two hospitals in China (Shanghai Changzheng Hospital and 254th Hospital of Chinese People's Liberation Army in Tianjin), in men and women without urinary tract infection, aged 18-75 years, who required urethral catheterisation. Patients who were pregnant, perinatal, or allergic to silicon rubber or protein, or who had any other diseases (eg, cystitis, stress incontinence, mental or neurological disorders, or severe heart, liver, lung, or kidney failures) not suitable for the study were excluded. All patients who provided written informed consent were enrolled and assigned to groups using a random envelope. Patients received Foley catheters with (test group) and without (controls) the coating. Primary outcomes were diff erences between groups in bacterial colony count and amount of mineral deposition, analysed by Fisher exact test, and leucocytes and occult blood in urine, analysed by χ²/Fisher exact test. To reduce uncertainty owing to participants' use of antibiotics, we designed two-section sampling projects to assess catheter sections in the bladder and out of the urinary meatus. Chinese Food and Drug Administration (Jiangsu province) regulatory code 2014-ZC-440; hospital ethics committee coding EC-Device-2014-18 and EC-Device-2015-08. Findings Between July, 2014, and November, 2015, we randomly assigned 67 patients to the test group and 65 to the control group. Urinary mineral deposition occurred in fi ve (8%) patients in test group and 22 (34%) in control group (χ²=14•11, OR 0•16, 95% CI 0•06-0•45, p=0•0002). Bacterial colonisation was present in catheter sections out of the urinary meatus for 18 test patients (27%) and 44 (68%) controls (OR 0•16, 95% CI 0•08-0•37, p<0•0001), and in bladder for 27 (40%) test patients and 44 (68%) controls (0•32, 0•16-0•66, p<0•0001). There were no signifi cant diff erences between the groups in leucocytes and occult blood in urine before, during, or after catheterisation (p>0•05). No adverse events occurred in either group. Interpretation The coating can eff ectively and safely inhibit biofi lm formation on catheter surface and reduce urinary mineral deposition.

Antibiotic prophylaxis for urodynamic testing in women: a systematic review

“…The results of this review mean we must advocate for more research in this area, particularly female-specific research, such that practitioners performing UDS can make an informed decision with regard to the benefits of antibiotic prophylaxis versus the possible negative effects including increased antibiotic resistance and decreased microbiome diversity [9, 19, ]. Of course, other considerations to decrease the risk of infection associated with catheterization are already being explored in the form of protein, silver and nitrazine coating of catheters, surface micropatterns on catheters and variable preprocedural meatal cleaning [21][22][23][24][25][26]. In addition, alternative UTI prophylaxis with cranberry juice, cranberry extract, Nacetylcysteine and lactobacilli is also an emerging field of research to consider in this ongoing debate [15,16,[27][28][29][30][31][32][33].…”

A Versatile Approach for the Synthesis of Antimicrobial Polymer Brushes on Natural Rubber/Graphene Oxide Composite Films via Surface-Initiated Atom-Transfer Radical Polymerization

“…Natural rubber (NR) is an essential material in engineering applications. It is widely used in medical fields due to its high wear and barrier property levels; it is used in supplies such as medical gloves [ 1 , 2 ], condoms [ 3 , 4 , 5 ], and catheters [ 6 ]. The preventative properties of natural rubber latex (NRL) can be applied to manufacture products that isolate pathogens, and NRL is one of the best natural raw materials for biomedical products.…”