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

Central Venous Catheter Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Other: 24hrs dressings change; Other: 7days dressings change

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: 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).
Experimental: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Bacterial colonization in the skin under dressing	incidence of bacterial colonization in the skin under dressing :7days or 8days after insertion,when nurse change the CVC 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. Samples were inoculated on Petri dishes respectively.The type and quantity of bacteria will be reported by the Laboratory. The colony number above 20 CFU(colony-forming units) / cm2 means Bacterial colonization occurred.	7days or 8days of central venous catheter insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Medical adhesive-related skin injury(MARSI)	MARSI:persistent erythema and / or other skin abnormalities within 30 minutes or more after nurse change the dressings	from cvc insertion to 7days or 8days

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Xiamen Children's Hospital; Shenzhen Children's Hospital; Anhui Province Children's Hospital
• Investigators: Study Chair: Ying Gu, doctor, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: dressing; bacterial colonization; Central venous access device; medical adhesive-related skin injury
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: FNDGJ202008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No