Effect of central venous catheter dressing replacement frequency on skin bacterial colonization: a study protocol for a multicenter randomized controlled study

Abstract Background: Bloodstream infections of central venous catheters （CVC） are often caused by the migration of organisms from the insertion site or under the dressing. According to the evidence summary, it is recommended to change the dressing 24hrs after insertion, which would cause central line-associated bloodstream infection (CLABSI) and medical adhesive-related skin injury (MARSI) in the previous audits we had implemented. The purpose of this study is to evaluate the hypothesis that not changing the dressing after 24hrs of CVC insertion is not inferior to changing after 24 hrs in terms of the occurrence of bacterial colonization on the seventh or eighth day after the insertion.Method: A multicenter prospective randomized controlled non-inferiority trial of pediatric patients with CVC whether the dressing is changed 24hs after CVC insertion. A total of 280 children will be enrolled according to the inclusion and exclusion criteria. The main outcome will be the occurrence of bacterial colonization under dressings. The secondary outcomes will be the incidence of CLABSI and MARSI. Discussion: This study investigates the safety and feasibility of not changing the dressing after 24hs of CVC. The result may update the evidence of CVC maintenance and form a new policy and process of CVC maintenance.Trial registration: ClinicalTrials.gov, NCT04806776. Initially registered on 17th March 2021,the recruitment will be completed on June 1st ,2022.