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Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

Primary Purpose

Catheter-Related Infections

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Standard dressing

Chlorhexidine gluconate -impregnated dressing group

About this trial

This is an interventional prevention trial for Catheter-Related Infections focused on measuring Chlorhexidine dressing, Central venous catheter, Central line associated bloodstream infection, Colonization, Pediatric critical care

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard dressing group

Chlorhexidine gluconate -impregnated dressing group

Arm Description

Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.

Outcomes

Primary Outcome Measures

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.

Central-line associated bloodstream infection rate

The presence of either catheter-related bloodstream infections or primary bloodstream infection

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04794231

First Posted

February 22, 2021

Last Updated

March 11, 2021

Sponsor

Istanbul Medeniyet University

1. Study Identification

Unique Protocol Identification Number

NCT04794231

Brief Title

Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter-Related Infections

Keywords

Chlorhexidine dressing, Central venous catheter, Central line associated bloodstream infection, Colonization, Pediatric critical care

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The laboratory microbiologist was blinded to the study groups. The two dressings were visibly different, and consequently, it was not possible to blind the patients, PICU staff or the investigators who collected data in the PICU.

Allocation

Randomized

Enrollment

307 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard dressing group

Arm Type

Active Comparator

Arm Description

Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.

Arm Title

Chlorhexidine gluconate -impregnated dressing group

Arm Type

Active Comparator

Arm Description

Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.

Intervention Type

Other

Intervention Name(s)

Standard dressing

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Chlorhexidine gluconate -impregnated dressing group

Intervention Description

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).

Primary Outcome Measure Information:

Title

Catheter-related bloodstream infection rate

Description

Time Frame

Up to 7 days after catheter removal

Title

Central-line associated bloodstream infection rate

Description

The presence of either catheter-related bloodstream infections or primary bloodstream infection

Time Frame

Up to 7 days after catheter removal

Title

Primary bloodstream infection rate

Description

Time Frame

Up to 7 days after catheter removal

Title

Catheter colonization rate

Description

Time Frame

Up to 7 days after catheter removal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi

City

Istanbul

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

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