Clinical trial NCT04806776: Frequence of Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit
Official title: Central Venous Catheter Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Keywords: Central venous access device
dressing
bacterial colonization
medical adhesive-related skin injury
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Xiamen Children's Hospital
name: Shenzhen Children's Hospital
name: Anhui Province Children's Hospital
First posted: 2021-03-19
Enrollment: 280
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is non-inferiority trial design.The relationship between whether dressing change 24hrs after CVC (central venous catheter) catheterization and bacterial colonization of the skin.

Detailed description: Central venous catheter (CVC) was punctured directly through jugular vein, subclavian vein and femoral vein, and its tip is located in superior vena cava or inferior vena cava. CVC is widely used in ICU because of its kinds of advantages. However, CVC, as an invasive puncture method, may bring more complications. The incidence of central line associated bloodstream infection (CLABSI) was 1.33-31.6/1000 catheterization day , and the death rate due to CVC associated bloodstream infection is 3-5% . Therefore, various organizations have formulated guidelines for the prevention of CLABSI and best evidence summary . From October 2019 to April 2020, taking the children's hospital of Fudan University as the leading unit, PICU of children's Hospital Affiliated to Zhejiang University, Anhui children's Hospital, Xiamen children's Hospital, Shenzhen Children's Hospital and Guangzhou Women's and Children's medical center as the cooperation units, carried out children's central venous catheterization Multi center research on best practices of management and maintenance. It was found that changing dressings 24 hours after catheterization may increase the incidence of MARSI, and repeatedly exposing dressings may also increase the incidence of CLABSI. The research team returned to the original evidence and consulted the guidelines. It was found that: under the premise of achieving the maximum aseptic catheterization, the guidelines issued by various institutions did not mention that the application should be replaced 24 hours after catheterization; however, the evidence was mentioned in the evidence summary, but there was no support from the relevant original literature. Therefore, it is worth discussing whether children need to change dressings 24 hours after catheterization. This study is non-inferiority trial design.

Eligibility criteria: Inclusion Criteria:

* CVC catheter was placed in the research site (including the operating room and PICU);
* only one CVC catheter was placed during the research time

Exclusion Criteria:

* catheter was inserted from another hospital and in emergency;
* the tip of CVC catheter was not in the upper and lower vena cava;
* children had history of CLABSI before the study

Primary outcomes:
measure: Incidence of Bacterial colonization in the skin under dressing
timeFrame: 7days or 8days of central venous catheter insertion
Secondary outcomes:
measure: Incidence of Medical adhesive-related skin injury(MARSI)
timeFrame: from cvc insertion to 7days or 8days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Gu, doctor
role: STUDY_CHAIR
References: