Skip to main content
OpenTrials
Completed

NCT Number: NCT04794231

Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard dressing

Other

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)

Chlorhexidine gluconate -impregnated dressing group

Other

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 outcomes

  1. Catheter-related bloodstream infection rate

    Time frame: Up to 7 days after catheter removal

    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.

  2. Central-line associated bloodstream infection rate

    Time frame: Up to 7 days after catheter removal

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

  3. Primary bloodstream infection rate

    Time frame: Up to 7 days after catheter removal

    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

  4. Catheter colonization rate

    Time frame: Up to 7 days after catheter removal

    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

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2021
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.