search
Back to results

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

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
24hrs dressings change
7days dressings change
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Infections focused on measuring Central venous access device, dressing, bacterial colonization, medical adhesive-related skin injury

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

24hrs dressing change

7d change dressing

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2021
Last Updated
April 12, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Xiamen Children's Hospital, Shenzhen Children's Hospital, Anhui Province Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04806776
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Xiamen Children's Hospital, Shenzhen Children's Hospital, Anhui Province Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Central venous access device, dressing, bacterial colonization, medical adhesive-related skin injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24hrs dressing change
Arm Type
Active Comparator
Arm 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).
Arm Title
7d change dressing
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
24hrs dressings change
Intervention Description
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
Intervention Name(s)
7days dressings change
Intervention Description
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).
Primary Outcome Measure Information:
Title
Incidence of Bacterial colonization in the skin under dressing
Description
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.
Time Frame
7days or 8days of central venous catheter insertion
Secondary Outcome Measure Information:
Title
Incidence of Medical adhesive-related skin injury(MARSI)
Description
MARSI:persistent erythema and / or other skin abnormalities within 30 minutes or more after nurse change the dressings
Time Frame
from cvc insertion to 7days or 8days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Gu, doctor
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs