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

NCT ID: NCT04806776

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-07
• Study Completion Date: 2022-12-30

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.

Conditions

Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

24hrs dressing change

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).

Group Type: ACTIVE_COMPARATOR

24hrs dressings change

Intervention Type: OTHER

The first dressing change and sampling were completed 24 hours after catheterization in the operating room or PICU.When bedside nurse remove the dressing ,the researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately.Then the specimen delivered to Laboratory..Then the second dressing change and sampling were completed 7days later(if there is no clinical indication occur,such leaking,blood).

7d change dressing

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).

Group Type: EXPERIMENTAL

7days dressings change

Intervention Type: OTHER

The first dressing change and sampling were completed 7 days after catheterization in the operating room or PICU.When bedside nurse remove the dressing ,the researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately.Then the specimen delivered to Laboratory..(if there is no clinical indication occur,such leaking,blood).

Interventions

24hrs dressings change

The first dressing change and sampling were completed 24 hours after catheterization in the operating room or PICU.When bedside nurse remove the dressing ,the researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately.Then the specimen delivered to Laboratory..Then the second dressing change and sampling were completed 7days later(if there is no clinical indication occur,such leaking,blood).

Intervention Type: OTHER

7days dressings change

The first dressing change and sampling were completed 7 days after catheterization in the operating room or PICU.When bedside nurse remove the dressing ,the researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately.Then the specimen delivered to Laboratory..(if there is no clinical indication occur,such leaking,blood).

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiamen Children's Hospital

OTHER

Sponsor Role: collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

Anhui Province Children's Hospital

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Gu, doctor

Role: STUDY_CHAIR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FNDGJ202008

Identifier Type: -

Identifier Source: org_study_id