Clinical trial of junction seals for the prevention of urinary catheter-associated bacteriuria.

ABSTRACT

BACKGROUND: Preconnected catheter systems with sealed junctions have been associated with reduced rates of bacteriuria and mortality. A clinical trial was undertaken to evaluate the effectiveness of a junction seal applied after catheter insertion for preventing bacteriuria and reducing mortality. METHODS: Patients undergoing transurethral catheterization at a community hospital were randomized within 24 hours of catheter insertion to receive either a tape seal applied to the catheter-drainage tubing junction or no tape seal. Catheter urine cultures and catheter care violations were monitored daily until catheter removal or patient discharge. RESULTS: Overall, 124 (13.7%) of 903 patients in the group receiving a junction seal acquired bacteriuria, compared with 125 (14.9%) of 837 patients in the control group (P = .52, odds ratio = 0.91, 95% confidence interval, 0.69 to 1.20). Multivariate analysis revealed that only female gender and lack of systemic antibiotic use independently correlated with the development of bacteriuria; neither junction treatment randomization nor disconnection of the junction was associated with bacteriuria. Survival curve analysis of patients stratified by gender and antibiotic use revealed no significant differences in the rate of bacteriuria between treatment groups. The overall mortality in the tape seal group was less than that in the control group (6.6% vs. 8.0%, respectively), but not to a statistically significant extent despite stratification by antibiotic use. CONCLUSIONS: The use of a tape seal applied to the catheter-drainage tubing junction within 24 hours of catheter insertion was not associated with significantly lower rates of bacteriuria and mortality in patients undergoing short-term catheterization.