Frequence of Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit

Fudan University

Status: Completed

Conditions: Bacterial Infections

Treatments: Other: 7days dressings change; Other: 24hrs dressings change

Study type: Interventional

Funder types: Other

Identifiers

NCT04806776

FNDGJ202008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

24hrs dressing change

Active Comparator group

Description:

The first dressing change and sampling were completed 24 hours after catheterization in the operating room or PICU Then the second dressing change and sampling were completed 7days later(if there is no clinical indication occur,such leaking,blood).

Treatment:

Other: 24hrs dressings change

7d change dressing

Experimental group

Description:

Dressing change and sampling were completed 7days after catheterization in the operating room or PICU.(if there is no clinical indication occur,such leaking,blood).

Treatment:

Other: 7days dressings change