Article type
Abstract
"Background The optimal timing of the first dressing change after CVC insertion remains ambiguous in CVC maintenance. In some clinical guidelines, with consideration of minimizing catheter related bloodstream infection, recommended a 24-hour interval of first dressing change. Objective To test the hypothesis that dressing change at seven days after CVC insertion dose not significantly increase the risk of catheter related bloodstream infection in pediatric critical patients compared with an additional dressing change at 24-hour after insertion.
Method A multicenter, randomized controlled noninferiority trial was conducted in pediatric ICUs of four hospitals in China between April 7, 2021, to December 30, 2022. Patients aged 1 month to 18 years admitted to ICU with a newly inserted CVC were eligible. Enrolled participants were assigned (1:1) based on block randomization (block size=4) to change dressings every seven days with an additional change 24 hours after CVC insertion (the control group) or to change dressings every seven days after CVC insertion (the experimental group), unless clinical indicated dressing change was taken. The primary outcome was the occurrence of skin bacterial colonization under transparent dressings at 7 days and 8 days after CVC insertion for the experimental and control group respectively.
Results In total 280 participates were randomized. In the ITT population, bacterial colonization occurred in 25.6% patients in the experimental group and 26.8% in the control group (between-group difference, -1.1%; 95% CI, -13.0 to 10.7), with the upper limit of risk difference below the prespecified noninferiority margin of 20%. The incidence of CLABSI did not significantly differ (1.42/1000 catheter days vs 2.72/1000 catheter days for the experimental and control group, respectively). Only one MARSI event occurred in the control group.
Conclusions Among pediatrics critically ill patients in ICU with only one non-tunneled CVC, dressing change seven days after insertion did not significantly increase the risk of occur of skin bacterial colonization or the incidence of CLABSI. This evidence has the potential to translate into the current clinical practice.
Resgsteration ClinicalTrial.gov Identifier: NCT04806776, and study start at April 7th ,2021
"
Method A multicenter, randomized controlled noninferiority trial was conducted in pediatric ICUs of four hospitals in China between April 7, 2021, to December 30, 2022. Patients aged 1 month to 18 years admitted to ICU with a newly inserted CVC were eligible. Enrolled participants were assigned (1:1) based on block randomization (block size=4) to change dressings every seven days with an additional change 24 hours after CVC insertion (the control group) or to change dressings every seven days after CVC insertion (the experimental group), unless clinical indicated dressing change was taken. The primary outcome was the occurrence of skin bacterial colonization under transparent dressings at 7 days and 8 days after CVC insertion for the experimental and control group respectively.
Results In total 280 participates were randomized. In the ITT population, bacterial colonization occurred in 25.6% patients in the experimental group and 26.8% in the control group (between-group difference, -1.1%; 95% CI, -13.0 to 10.7), with the upper limit of risk difference below the prespecified noninferiority margin of 20%. The incidence of CLABSI did not significantly differ (1.42/1000 catheter days vs 2.72/1000 catheter days for the experimental and control group, respectively). Only one MARSI event occurred in the control group.
Conclusions Among pediatrics critically ill patients in ICU with only one non-tunneled CVC, dressing change seven days after insertion did not significantly increase the risk of occur of skin bacterial colonization or the incidence of CLABSI. This evidence has the potential to translate into the current clinical practice.
Resgsteration ClinicalTrial.gov Identifier: NCT04806776, and study start at April 7th ,2021
"