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

• ClinicalTrials.gov Identifier: NCT04806776
• Recruitment Status: Recruiting
• First Posted: March 19, 2021
• Last Update Posted: January 28, 2022
• Sponsor: Children's Hospital of Fudan University
• Collaborators: Xiamen Children's Hospital; Shenzhen Children's Hospital; Anhui Province Children's Hospital
• Information provided by (Responsible Party): Children's Hospital of Fudan University

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.

Condition or disease	Intervention/treatment	Phase
Bacterial Infections	Other: 24hrs dressings change; Other: 7days dressings change	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Central Venous Catheter Dressing Change and Bacterial Colonization in Pediatric Intensive Care Unit
• Actual Study Start Date: April 7, 2021
• Estimated Primary Completion Date: March 1, 2022
• Estimated Study Completion Date: March 31, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. Incidence of Bacterial colonization in the skin under dressing [ Time Frame: 7days or 8days of central venous catheter insertion ]
   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 :

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

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: wenchao wang, master; 18217752179 ext 86; 18217752179@126.com

Contact: Ying Gu, doctor; 18017590969 ext 86; guying0128@aliyun.com

Locations

China, Shanghai

Children's Hospital of Fudan University; Recruiting

Shanghai, Shanghai, China, 201102

Contact: Ying Gu, doctor

Sponsors and Collaborators

Children's Hospital of Fudan University

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

More Information

• Responsible Party: Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT04806776
• Other Study ID Numbers: FNDGJ202008
• First Posted: March 19, 2021
• Last Update Posted: January 28, 2022
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Children's Hospital of Fudan University:

Central venous access device; dressing; bacterial colonization; medical adhesive-related skin injury

Additional relevant MeSH terms:

Bacterial Infections; Bacterial Infections and Mycoses; Infections