Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

Istanbul Medeniyet University

Status

Completed

Conditions

Catheter-Related Infections

Treatments

Other: Chlorhexidine gluconate -impregnated dressing group

Other: Standard dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT04794231

2018/0203

Details and patient eligibility

About

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.

Full 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.

Enrollment

307 patients

Sex

All

Ages

1 month to 17 years old

Volunteers

No 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.