A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates

Neonates who require a central venous catheter (CVC) for prolonged vascular access experience high rates of catheter-related bloodstream infection (CR BSI). Purpose. A multicenter randomized clinical trial was undertaken to ascertai n the efficacy of a novel chlorhexidine-impregnated dressing (Biopatch Anti microbial Dressing) on the CVC sites of neonates for the prevention of cath eter tip colonization, CRBSI, and bloodstream infection (BSI) without a sou rce. Setting. Six level III neonatal intensive care units. Patients Studied. Neonates admitted to study units who would require a CVC for at least 48 hours. Methods. Eligible infants were randomized before catheter placement to 1 of the 2 catheter site antisepsis regimens: 1) 10% povidone-iodine (PI) skin scrub, or 2) a 70% alcohol scrub followed by placement of a chlorhexidine-i mpregnated disk over the catheter insertion site. A transparent polyurethan e dressing (Bioclusive Transparent Dressing) was used to cover the insertio n site in both study groups. Primary study outcomes evaluated were catheter tip colonization, CRBSI, and BSI without an identified source. Results. Seven hundred five neonates were enrolled in the trial, 335 random ized to receive the chlorhexidine dressing and 370 to skin disinfection wit h PI (controls). Neonates randomized to the antimicrobial dressing group we re less likely to have colonized CVC tips than control neonates (15.0% vs 2 4.0%, relative risk [RR]: 0.6 95% confidence interval [CI]: 0.5-0.9). Rates of CRBSI (3.8% vs 3.2%, RR: 1.2, CI: 0.5-2.7) and BSI without a source (15 .2% vs 14.3%, RR: 1.1, CI: 0.8-1.5) did not differ between the 2 groups. Lo calized contact dermatitis from the antimicrobial dressing, requiring cross over into the PI treatment group, occurred in 15 (15.3%) of 98 exposed neon ates weighing less than or equal to 1000 g. No neonates in the PI group dev eloped contact dermatitis. Conclusion. The novel chlorhexidine- impregnated dressing, replaced weekly, was as effective as cutaneous disinfection with 10% PI and redressing the site every 3 to 7 days for preventing CRBSI and BSI without a source in cri tically ill neonates requiring prolonged central venous access. The risk of local contact dermatitis under the chlorhexidine dressing limits its use i n low birth weight infants who require prolonged central access during the first 2 weeks of life.