Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing for the Prevention of Central-line Associated Blood Stream Infection and Colonization in Critically Ill Pediatric Patients: A Randomized Controlled Trial

Investigators have designed a single-center randomized controlled trial to compare chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to their effects on the infection outcomes. The study was condcuted in the pediatric intensive care unit in the 18 months period.

Study Overview

• Status: Completed
• Conditions: Catheter-Related Infections
• Intervention / Treatment: Other: Standard dressing; Other: Chlorhexidine gluconate -impregnated dressing group

Detailed Description

The single-center randomized controlled trial study aimed to compare chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to their effects on the frequency of central-line associated bloodstream infection (CLABSI), catheter related bloodstream infection (CRBSI), primary bloodstream infection (BSI) and catheter colonization in critically ill pediatric patients with short-term non-tunneled central venous catheter (CVC) in a pediatric intensive care unit (PICU) of a tertiary referral hospital in Turkey.. Pediatric patients aged 1 month to 18 years admitted to our PICU between May 2018 and December 2019, who had received placement of a short-term non-tunneled CVC which had stayed in place for at least 48 hours were included into the study. The patients were grouped with respect to the type of catheter fixation they had received, either with CHG-impregnated dressing or standard dressing, which were assigned in a randomized fashion. The groups were compared with regard to the frequencies of CLABSI, CRBSI, primary BSI and catheter colonization, as well as microorganism etiology. Any adverse event related to catheter dressing were recorded. Independent risk factors of CLABSI frequency were analyzed.

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• being aged age less than 18 years old,
• providing informed consent to participate in the study
• insertion of a short term non-tunneled, percutaneously inserted CVC (jugular, subclavian, or femoral) that would remain in place for greater than 48 hours during PICU admission.

Exclusion Criteria:

Patients were excluded if they:

• had known allergies to CHG-impregnated or standard dressing,
• would receive insertion of any other type of CVC device (e.g., peripherally inserted CVC, tunneled CVC), were included in the study previously,
• had a current BSI (positive blood culture within 48 hours),
• had received CVC insertion within the 30 days prior to PICU admission.

Additionally, investigators also excluded patients in which

• catheterization had not been performed by the PICU specialist,
• those that were discharged from the PICU with indwelling CVC,
• patients who received extracorporeal membrane oxygenation,

Individuals in which the following events were recorded:

• Accidental catheter removal,
• CVC removal before 48 hours, and
• death within 48 hours after CVC insertion.

In the event that a patient required CVC re-insertion after the initial catheter was removed (due to any reason), only the first application was included in the study -given that any other exclusion criteria did not exclude the patient. Finally, if a patient required catheter reinsertion before the completion of the 48-hour catheter-infection monitoring of the initial application, the first catheterization was excluded from 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: Standard dressing group; Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.	Other: Standard dressing; a standard breathable, hypoallergenic, transparent dressing (TegadermTM 1635 [8.5 x 10.5cm] or 1633 [7 × 8.5 cm] depending on patient size; 3M, Neuss, Germany)
Active Comparator: Chlorhexidine gluconate -impregnated dressing group; Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.	Other: Chlorhexidine gluconate -impregnated dressing group; A chlorhexidine gluconate -gel impregnated transparent dressing (TegadermTM CHG 1660R [7 x 8.5 cm] or [11.5 x 8.5 cm] depending on patient size; 3M, Neuss, Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter-related bloodstream infection rate	Catheter infections were identified according to NHSN and IDSA criteria. Catheter-related bloodstream infection defined as bacteremia/fungemia in a patient with an intravascular catheter with at least 1 positive blood culture obtained from a peripheral vein sampled immediately before or within 48 hours after catheter removal, clinical manifestations of infections (ie, fever, chills, and/or hypotension), and no apparent source for the bloodstream infection except the catheter.	Up to 7 days after catheter removal
Central-line associated bloodstream infection rate	The presence of either catheter-related bloodstream infections or primary bloodstream infection	Up to 7 days after catheter removal
Primary bloodstream infection rate	The presence of patients with central venous catheter who had (i) at least one positive blood culture, (ii) clinical manifestation of infection (i.e., fever, chills, and/or hypotension), (iii) no apparent source for the BSI except the catheter, and (iv) no positivity in catheter culture	Up to 7 days after catheter removal
Catheter colonization rate	The growth of >15 CFU in catheter tip cultures in the absence of local or systemic signs of infection or lack of growth in the two blood samples, or in the event that the two cultures showed growth of the same microorganism which was different from the microorganism isolated in the culture of the catheter tip	Up to 7 days after catheter removal

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Central venous catheter; Colonization; Pediatric critical care; Chlorhexidine dressing; Central line associated bloodstream infection
• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2018/0203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After research will be ended, all data (except personel data which was reflect the patient in his/her own) will be shared to other researchers.
• IPD Sharing Time Frame: April 2021- August 2021
• IPD Sharing Access Criteria: All applications related to scientific goals would be accepted.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No