Timing of the first dressing change after CVC insertion in pediatric critically ill patients: a randomized controlled, non-inferiority trial.

The optimal timing of the first dressing change after central venous catheter (CVC) insertion remains unclear. To test whether a first dressing change at seven days is non-inferior to an additional change at 24 h, we conducted a multicenter randomized controlled non-inferiority trial in four Chinese pediatric ICUs (April 2021-December 2022). A total of 280 patients aged 1 month to 18 years with a newly inserted CVC were randomly assigned to the control group (dressing change at 24 h, then every seven days) or the experimental group (first dressing change at seven days). The primary outcome was skin bacterial colonization under the transparent dressing, assessed at day 7 (experimental) and day 8 (control). In the intention-to-treat population, colonization occurred in 25.6% of experimental patients and 26.8% of controls (difference, - 1.1%; 95% CI, - 13.0% to 10.7%), with the upper CI limit below the prespecified noninferiority margin of 20%. Catheter related bloodstream infection(CRBSI) rates were 1.42 vs. 2.72 per 1,000 catheter days (no significant difference). Only one skin injury occurred. Delaying the first dressing change to seven days did not increase skin bacterial colonization and showed no significant difference in CRBSI, suggesting that this practice is safe with respect to colonization risk. Definitive conclusions regarding infection safety require a larger trial.